(63 days)
No
The description focuses on the physical properties and materials of the marker and its delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
A therapeutic device is used for treating or curing a disease. This device is a marker used for imaging purposes after a biopsy, not for treatment.
No
This device is a marker intended to permanently mark a breast biopsy site for future identification under imaging, not to diagnose a condition.
No
The device description clearly states it is a two-component marker consisting of a resorbable hydrogel and a metallic component, which are physical hardware components. It also mentions applicator devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The HydroMARK® Breast Biopsy Site Marker is a device that is implanted into the body during a biopsy procedure. Its purpose is to physically mark the location of the biopsy site for future imaging and potential surgical removal.
- Intended Use: The intended use clearly states it is used to "mark tissue during a percutaneous breast biopsy procedure" and be visible under various imaging modalities. This is a physical marking function, not a diagnostic test performed on a specimen.
The device is a medical device, specifically an implantable marker, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HydroMARK® Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
Product codes
NEU
Device Description
The HydroMARK® Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in applicator devices designed to fit into the following:
- 8G Flexible Applicator System fits into:
- O Mammotome revolve® 8G Probe (9cm with and without Specimen Management System and 12cm without Specimen Management System)
- EnCor 7G Directional Vacuum-Assisted Biopsy Devices o
- . 10G Flexible Applicator System fits into:
- Mammotome revolve® 10G Probe (9cm with and without Specimen Management O System and 12cm without Specimen Management System)
- EnCor 10G Directional Vacuum-Assisted Biopsy Devices o
- ATEC 9G Biopsy Handpiece Introducers O
The HydroMARK® Breast Biopsy Site Marker is a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogel material expands with fluid contact and is then resorbed by the body over time. Since the hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI. The wire coil is available in (3) three shapes:
- Barrel Shape
- Open Coil Shape
- Butterfly Shape
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, X-ray, MRI
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Bench Performance Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to confirm that the device meets all design and functional requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device].
Non-Clinical Performance Bench Testing included:
- Design Verification by Document Analysis
- Finite Element Analysis (FEA) for the determination of the safety factor of Daybreak Cannula vs. MammoMARK Cannula that will reduce the tip shear occurrence
- Hydrogel Verification Testing
- Compatibility Verification Testing: Deployment and Removal of the Markers in each Probe
- Mechanical Verification Testing
Human Factors/Usability Testing included:
- Simulated Use Testing
- Formative Studies (FE1) and (FE2)
Biocompatibility Testing included:
- GLP Cytotoxicity (MEM Elution) Testing
Chemical Characterization Testing included:
- Exhaustive Extractables Testing (Exhaustive Extractables Report)
- Toxicological Risk Assessment
Bioburden Testing, Sterility Testing, Sterility Testing, Endotoxin Testing, Residual Analysis Testing, Transit Verification Testing, 12 Month and 18 Month Shelf-Life Testing included:
- Bioburden Testing
- Sterilization Testing (Sterilization Load Configuration / Challenge Device Placements / Biological Indicator Placements)
- Sterility Testing (Sterility Testing of the Natural Product, Sterility Testing of the Biological Indicators)
- Endotoxin Testing
- Residual Analysis Testing
- Shelf-Life / Transit Verification Testing (12 Month Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing; 18 Month Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing)
Key Results: All tests PASSED. The studies demonstrated that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device, supporting a determination of substantial equivalence (SE).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2020
Devicor Medical Products, Inc Rhonda Kops Senior Regulatory Manager 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241
Re: K203097
Trade/Device Name: HydroMARK Breast Biopsy Site Markers Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: October 12, 2020 Received: October 14, 2020
Dear Rhonda Kops:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203097
Device Name HydroMARK® Breast Biopsy Site Marker
Indications for Use (Describe)
The HydroMARK® Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K203097 p. 1 of 16
Image /page/3/Picture/1 description: The image shows the logo for Devicor Medical Products, Inc. The logo consists of a stylized symbol resembling two overlapping crescent shapes on the left, followed by the word "DEVICOR" in bold, sans-serif font. Below "DEVICOR" is the text "MEDICAL PRODUCTS, INC." in a smaller, sans-serif font. The logo is black and white.
510(K) SUMMARY
I. SUBMITTER [Per 807.92(a)(1)]
Sponsor/Manufacturer
Devicor Medical Products, Inc. 300 E. Business Way, Fifth Floor Cincinnati, OH 45241 U.S.A.
Establishment Registration Number 3008492462
Official Correspondent for Devicor Medical Products, Inc.
Rhonda M. Kops, RAC Phone: (513)-864-9272 (office) Email: rhonda.kops@mammotome.com
Date Prepared
October 12, 2020
II. DEVICE [Per 807.92(a)(2)]
| Device Trade/Proprietary Name: | HydroMARK® Breast Biopsy Site Marker |
|---|---|
| Device Common or Usual Name: | Implantable Clip |
| Device Classification Name: | Marker, Radiographic, Implantable |
| Device Regulatory Classification: | Class II |
| Device Classification Regulation: | 21 CFR §878.4300 |
| Product Code: | (NEU) – Marker, Radiographic, Implantable |
| Submission Type: | Premarket Notification [510(k) Submission] |
| Review Panel: | General & Plastic Surgery |
| Premarket Review: | Surgical and Infection Control Devices (OHT4) |
| Infection Control and Plastic Surgery Devices (DHT4B) |
III. PREDICATE DEVICE [Per 807.92(a)(3)]
| Predicate Device: | The Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Sponsor's own predicate device:
Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] The Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] in terms of the identical indications for use / intended use to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI. Substantial equivalency (SE) of the subject device has also been based on substantially equivalent usability, functionality, and performance characteristics as the predicate device. |
| ------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
| | The Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] is
substantially equivalent (SE) to the Sponsor's own reference device: |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K121113 and
K130537) [reference device] |
| Reference
Device: | The Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] is
additionally substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK®
Breast Biopsy Site Marker (K121113 and K130537) [reference device] in terms of the identical
indications for use / intended use to mark tissue during a percutaneous breast biopsy
procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray
and MRI. Substantial equivalency (SE) of the subject device has also been based on substantially
equivalent usability, functionality, and performance characteristics as the reference device. |
IV. DEVICE DESCRIPTION [Per 807.92(a)(4)]
The HydroMARK® Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in applicator devices designed to fit into the following:
- 8G Flexible Applicator System fits into:
- O Mammotome revolve® 8G Probe (9cm with and without Specimen Management System and 12cm without Specimen Management System)
- EnCor 7G Directional Vacuum-Assisted Biopsy Devices o
- . 10G Flexible Applicator System fits into:
- Mammotome revolve® 10G Probe (9cm with and without Specimen Management O System and 12cm without Specimen Management System)
- EnCor 10G Directional Vacuum-Assisted Biopsy Devices o
- ATEC 9G Biopsy Handpiece Introducers O
The HydroMARK® Breast Biopsy Site Marker is a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogel material expands with fluid contact and is then resorbed by the body over time. Since the hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI. The wire coil is available in (3) three shapes:
| Image: Barrel spring | Barrel Shape: Model Numbers [4010-05-08-T1 and 4010-05-10-T1] |
|---|---|
| Image: Open coil spring | Open Coil Shape: Model Numbers [4010-05-08-T3 and 4010-05-10-T3] |
| Image: Butterfly spring | Butterfly Shape: Model Numbers [4010-05-08-T4 and 4010-05-10-T4] |
5
The table below provides details of each HydroMARK® Breast Biopsy Site Marker including the model number, material, shape type/shape, and the length/OD of the marker and hydrogel.
| Model Number | Material | Shape Type | Shape | Marker
Length/OD | Hydrogel
Length/OD |
|---------------|----------|------------|------------------------|-----------------------------------------|-----------------------------------|
| 4010-05-08-T1 | Titanium | Barrel | Image: Barrel Shape | L: 0.039 - 0.049"
OD: 0.034 - 0.039" | L: 0.140-0.20"
OD:0.069-0.080" |
| 4010-05-08-T3 | Titanium | Open Coil | Image: Open Coil Shape | L: 0.061 - 0.081"
OD: 0.034 - 0.039" | L: 0.140-0.20"
OD:0.069-0.080" |
| 4010-05-08-T4 | Titanium | Butterfly | Image: Butterfly Shape | L: 0.060-0.080"
OD: 0.022 - 0.027" | L: 0.140-0.20"
OD:0.069-0.080" |
| 4010-05-10-T1 | Titanium | Barrel | Image: Barrel Shape | L: 0.039 - 0.049"
OD: 0.034 - 0.039" | L: 0.140-0.20"
OD:0.069-0.073" |
| 4010-05-10-T3 | Titanium | Open Coil | Image: Open Coil Shape | L: 0.061 - 0.081"
OD: 0.034 - 0.039" | L: 0.140-0.20"
OD:0.069-0.073" |
| 4010-05-10-T4 | Titanium | Butterfly | Image: Butterfly Shape | L: 0.060-0.080"
OD: 0.022 - 0.027" | L: 0.140-0.20"
OD:0.069-0.073" |
HydroMARK® Breast Biopsy Site Marker Coil Types & Shapes and Marker/Hydrogel Length/OD
V. INTENDED USE [Per 807.92(a)(5)]
The HydroMARK® Breast Biopsy Site Marker [subject device] is intended to mark tissue during a percutaneous breast biopsy procedure.
The Intended Use of the HydroMARK® Breast Biopsy Site Marker [subject device] and the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] are identical. Both devices are intended to mark tissue durinq a percutaneous breast biopsy procedure.
VI. INDICATIONS FOR USE [Per 807.92(a)(5)]
The HydroMARK® Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The Indications for Use Statement for the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] is identical to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device].
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]
The Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site
6
Marker (K161021) [predicate device] based on the identical indication for use / intended use and the same functional and performance characteristics of the subject device when compared to the predicate device. The differences between the subject device and predicate device do not raise new or different issues of safety and effectiveness. Non-Clinical Performance Testing and Device Compatibility Testing was conducted to demonstrate substantial equivalence (SE).
Rationale for Substantial Equivalence (SE)
The Devicor Medical Products, Inc. HydroMARK® Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] in terms of the identical indications for use / intended use and substantially equivalent usability, functionality, and performance characteristics as the predicate device. A detailed description of the similarities shared between the subject device and the predicate device, as well as, a description of the minor differences which do not raise new or different issues of safety and effectiveness, support a determination of substantial equivalency (SE).
Similarities
The Devicor Medical Products, Inc. HydroMARK® Biopsy Site Marker [subject device] shares the following same or similar characteristics as the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device]:
- . Intended Use / Indications for Use: Identical. The HydroMARK® Biopsy Site Marker [subject device] is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
- Marker Length: Same
- Marker Outer Diameter: Same
- Marker Cylinder Composition: Same
- Marker Coil Composition: Same
- Plunger Rod Material: Same
- Insertion Method into Biopsy Device: Same
- Marker to Biopsy Prove Alignment Confirmation: Same
- Deployment Action: Same
- Sterile Device: Same
- Sterility Assurance Level: Same
- Sterilization Method: Same
- Prescription Use: Same
- Use Environment: Same
Differences
There are minor differences that exist between the Devicor Medical Products, Inc. HydroMARK® Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] which do not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing [including: Design Verification by Document Analysis; Compatibility Verification Testing (Deployment and Removal of the Markers in each Probe), Mechanical Verification Testing; Finite Element Analysis (FEA) for the Determination of the Safety Factor of the Daybreak Cannula vs. MammoMARK® Cannula that will reduce tip shear occurrence; Hydrogel Verification Testing; Transit Verification Testing (Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing]; Human Factors/Usability Testing; Biocompatibility Testing; Chemical Characterization Testing; Bioburden Testing; Endotoxin Testing;
7
Residual Analysis Testing; Sterility Testing; Sterility Testing; and Shelf-Life Testing, was conducted to demonstrate substantial equivalence (SE). The subject device has the following characteristics which are different from the predicate device:
- Coil Shapes: Different. The addition of the T4 butterfly shaped coil to the HydroMARK® Biopsy . Site Markers [subject device] does not raise different questions of safety and effectiveness. This T4 butterfly shaped coil is the same as the commercially available T4 butterfly shaped coil used with the reference device cleared under (K130537). The T4 butterfly shaped coil is simply added as a third coil shape option for the subject device. Non-Clinical Performance Testing and Compatibility Testing was conducted to demonstrate substantial equivalence (SE).
- Overall Length of Device (as shipped): Different. The minor differences in the overall length of ● the HydroMARK® Biopsy Site Markers [subject device] (as shipped) does not raise different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Overall Length of Device (as deployed): Different. The subject device incorporates deployment detent to prevent plunger from retracting completely to provide further clearance in deployed state for post-procedure confirmation scans and provide user confirmation of successful deployment. The difference in the overall length of the device (as deployed) does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing has been conducted to demonstrate substantial equivalence (SE).
- . Plunger Rod Type: Different. The difference in the plunger rod type (flexible vs. rigid) does not raise new or different questions of safety and effectiveness. The predicate device plunger rod cleared under (K161021) has documented reportable events in the FDA's MAUDE database. Changing to a continuous flexible rod design eliminates these issues. The reference device plunger rod cleared under (K12113 and K130537) is the same flexible rod type as the subject device. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Plunger Tip Full Stroke Exposure: Different. The exposure of plunger tip at full stroke has been shortened in the subject device to prevent chance that the tip of the plunger can get caught outside of the cannula and negatively interact with the biopsy prove needle. The difference in the plunger tip full stroke exposure does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Plunger Rod Material: Different. The flexible materials used in the subject device are the same as the 4010-01-08 commercialized reference device cleared under (K12113). This difference does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Marker Aperture Position (Distal Tip to Top of Ramp): Different. The Marker Aperture Position (Distal Tip to Top of Ramp) in the subject device was moved towards the distal end of the device to improve deployment when the biopsy probe is in smallest aperture setting. This difference in marker aperture position does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Cannula Type: Different. The flexible cannula type in the subject device improves usability in Stereotactic procedures where marking through probe is difficult in upright biopsy cases. This difference in the cannula type (flexible versus rigid) does not raise new or different questions of safety and effectiveness. The flexible materials used in the subject device are the same as the 4010-01-08 commercialized reference device cleared under (K121113 and K130537). Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
8
- . Cannula Material: Different. The materials used for the flexible type cannula of the subject device are the same as the 4010-01-08 commercialized reference device cleared under (K12113). This difference does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Deployment Spring Composition: Different. The addition of the Stainless-Steel Compression Spring in the subject device ensures that the Plunger Tip fully retracts back into cannula while improving deployment control and feel for user. This difference in the composition of the deployment spring does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Sterility Guide: Different. Due to the change from a rigid to flexible cannula in the subject device, this sterility guide is added to the subject device to help users guide the marker into the biopsy device without the need of directly touching the marker tip. This difference does not raise new or different issues of safety or effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Device Bonding: Different. Due to the change from a rigid to flexible cannula in the subject device, the components are glued. This bonding method and the material is the same as the 4010-01-08 commercialized reference device cleared under (K12113). This difference does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- Sterile Packaging: The new packaging design will include development of a new carrier card, a protective sheath, sterile pouch, sales carton and shipper.
- . Shelf-Life: Different. The difference in shelf-life does not raise different questions of safety and effectiveness. Shelf-Life Testing was conducted to demonstrate substantial equivalence (SE).
- . Compatible Biopsy Devices: Different. The added marker option for 8GA revolve® and 7G EnCor (4010-05-08) does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing and Device Compatibility Testing was conducted to demonstrate substantial equivalence (SE).
- . Insertion Depth Confirmation: Different. The Depth Indicators were added to the subject device based on the Voice of Customer (VOC). This difference does not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
Overall Conclusions Regarding Substantial Equivalence (SE)
The fundamental scientific technology of subject device and the predicate device has not changed. Based on the data generated from the results of the Non-Clinical Performance Testing [including: Design Verification by Document Analysis; Compatibility Verification Testing (Deployment and Removal of the Markers in each Probe), Mechanical Verification Testing; Finite Element Analysis (FEA) for the Determination of the Safety Factor of the Daybreak Cannula vs. MammoMARK® Cannula that will reduce tip shear occurrence; Hydrogel Verification Testing; Transit Verification Testing (Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing]; Human Factors/Usability Testing; Biocompatibility Testing; Chemical Characterization Testing (Exhaustive Extractables and Toxicological Risk Assessment); Bioburden Testing; Residual Analysis Testing; Sterilization Testing; Sterility Testing conducted on the subject device, it may be concluded that the Devicor Medical Products, Inc. HydroMARK® Biopsy Site Marker [subject device] is as safe and effective, and performs as well as, the legally marketed predicate device, the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device]. The identical indications for use / intended use, and substantially equivalent usability, functionality and
9
performance characteristics for the proposed the Devicor Medical Products, Inc. HydroMARK® Biopsy Site Marker [subject device] have been assessed to be substantially equivalent (SE) to the predicate device, and any differences do not raise new or different issues of safety and effectiveness when compared to the predicate device.
Therefore, the Devicor Medical Products, Inc. HydroMARK® Biopsy Site Marker [subject device] is substantially equivalent to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device].
VIII. SUMMARY OF PERFORMANCE DATA AND PERFORMANCE TEST CONCLUSIONS [Per 807.92(b)(1)(2)(3)]
Non-Clinical Bench Performance Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to confirm that the device meets all design and functional requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. The following Non-Clinical Performance Data were provided in support of the substantial equivalence (SE) determination.
Non-Clinical Performance Bench Testing
- Non-Clinical Performance Bench Testing including: .
- o Design Verification by Document Analysis
- o Finite Element Analysis (FEA) for the determination of the safety factor of Daybreak Cannula vs. MammoMARK Cannula that will reduce the tip shear occurrence
- Hydrogel Verification Testing o
- Compatibility Verification Testing o
- Deployment and Removal of the Markers in each Probe
- Mechanical Verification Testing o
Human Factors/Usability Testing
- . Human Factors/Usability Testing including:
- o Simulated Use Testing
- o Formative Studies
Biocompatibility Testing
Refer to Section 15. Biocompatibility for additional details on the Biocompatibility – GLP Cytotoxicity (MEM Elution) Testing.
Biocompatibility Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The results of the Biocompatibility Testing confirmed the biological safety of the subject device and that it is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. The following Biocompatibility Data were provided in support of the substantial equivalence (SE) determination.
- . Biocompatibility Testing including:
- GLP Cytotoxicity (MEM Elution) Testing
10
Chemical Characterization Testing (including Exhaustive Extractables and Toxicological Risk Assessment)
Refer to Section 15. Biocompatibility for additional details on the Characterization Testing.
Chemical Characterization Testing (including Exhaustive Extractables and Toxicological Risk
Assessment) was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to assess potential toxicological risks of the device materials. The Chemical Characterization Testing confirmed no unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The results of the Chemical Characterization Testing confirmed the biological safety of the subject device and that it is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K12113 and K130537) [reference device]. The following Biocompatibility Data were provided in support of the substantial equivalence (SE) determination.
- Exhaustive Extractables Testing (Exhaustive Extractables Report)
- . Toxicological Risk Assessment
Bioburden Testing, Sterility Testing, Sterility Testing, Endotoxin Testing, Residual Analysis Testing, Transit Verification Testing, 12 Month and 18 Month Shelf-Life Testing
Refer to Section 14. Sterilization, Shelf-Life, and Packaging for additional details on these tests.
Bioburden Testing, Sterilization Testing, Sterility Testing, Residual Analysis Testing, Transit Verification Testing, 12 Month and 18 Month Shelf-Life Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to confirm that the device meets all design and functional requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K12113 and K130537) [reference device]. The following Non-Clinical Performance Data were provided in support of the substantial equivalence (SE) determination.
- Bioburden Testing ●
- . Sterilization Testing
- Sterilization Load Configuration / Challenge Device Placements / Biological Indicator o Placements
- . Sterility Testing
- o Sterility Testing of the Natural Product
- O Sterility Testing of the Biological Indicators
- . Endotoxin Testing
- Residual Analysis Testing
- Shelf-Life / Transit Verification Testing
- 12 Month Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), o and Seal Strength (Peel) Testing
- 18 Month Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), o and Seal Strength (Peel) Testing
High-Level Summary Tables of Non-Clinical Performance Testing
The table below includes a high-level summary of the Non-Clinical Bench Performance Testing data results submitted, referenced, or relied on in this premarket notification submission [510(k)] for a determination of substantial equivalence (SE).
11
| Finite Element Analysis (FEA) Simulation Study for the Determination of the Safety Factor of HydroMARK® Cannula vs. MammoMARK® Cannula that will Reduce the Tip Shear Occurrence | |
|---|---|
| Finite Element Analysis (FEA) Simulation Study for the Determination of the Safety Factor of HydroMARK® Cannula vs. MammoMARK® Cannula that will Reduce the Tip Shear Occurrence including: Safety Factor for HydroMARK® 8G Safety Factor for HydroMARK® 10G In-House Testing Standards: This Finite Element Analysis (FEA) Simulation Study for the Determination of the Safety Factor of the HydroMARK® Cannula vs. the MammoMARK® Cannula that will Reduce the Tip Shear Occurrence was conducted in accordance with In-House Testing Standards as established by Devicor Medical Products, Inc. The FEA Simulation study is based on design requirements of the product and are unique to this product type, there is no recognized testing standard. Devicor has created a procedure for testing that is consistently used for this type of testing. The test is not relevant to the predicate device and was developed for the subject device. | Test Results: PASSED |
| The results of these Finite Element Analysis (FEA) Simulation Study Data were provided in support of the substantial equivalence (SE) determination. |
Conclusion Supporting Substantial Equivalence (SE): The results of the Finite Element Analysis (FEA) Simulation Study for the Determination of the Safety Factor of HydroMARK® Cannula vs. MammoMARK® Cannula that will Reduce the Tip Shear Occurrence conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. |
| Hydrogel Verification Testing | |
| Hydrogel Verification Testing including: Hydrogel Hydration Testing Hydrogel Moisture Content Analysis In-House Testing Standards: This Hydrogel Verification Testing was conducted in accordance with In-House Testing Standards as established by Devicor Medical Products, Inc. Hydrogel Verification Testing is based on design requirements of the product and are unique to this product type, there is no recognized testing standard. Devicor has created a procedure for testing that is consistently used for this type of testing and is based on industry best practices for measuring Hydration of Hydrogels via swell ratio measurements. Residual Moisture is completed by a third-party test lab and uses standard Karl Fischer coulometric titration. The testing is based on testing used for the predicate device with additional and more stringent success criteria. | Test Results: PASSED
The results of these Hydrogel Verification Testing Data were provided in support of the substantial equivalence (SE) determination.
Conclusion Supporting Substantial Equivalence (SE): The results of the Hydrogel Verification Testing conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. |
| Compatibility Verification Testing | |
| Compatibility Verification Testing including: Deployment and Removal of the Markers in each Probe In-House Testing Standards: This Compatibility Verification Testing was conducted in accordance with In-House Testing Standards as established by Devicor Medical Products, Inc. Marker device compatibility has no relevant ASTM or ISO standard procedure. Devicor has created a procedure for testing that is consistently used for this type of testing. The testing is based on testing used for the predicate device with additional and more stringent success criteria. | Test Results: PASSED
The results of these Non-Clinical Bench Performance Data were provided in support of the substantial equivalence (SE) determination.
Conclusion Supporting Substantial Equivalence (SE): The results of the Compatibility Verification Testing conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. |
| Mechanical Verification Testing including: Marker Deployment and Sterile Guide Release Test
for 8G & 10G HydroMARK® Pushrod Self Retraction Testing for 8G & 10G
HydroMARK® HydroMARK® Bond Strength Testing In-House Testing Standards: This Mechanical Verification
Testing was conducted in accordance with In-House Testing
Standards as established by Devicor Medical Products, Inc.
Mechanical Verification Testing is based on design requirements
of the product and are unique to this product type, there is no
recognized testing standard. Devicor has created a procedure
for testing that is consistently used for this type of testing. The
testing is based on testing used for the predicate device with
additional and more stringent success criteria. | Test Results: PASSED
The results of these Non-Clinical Bench Performance Data were
provided in support of the substantial equivalence (SE)
determination.
Conclusion Supporting Substantial Equivalence (SE): The results of
the Mechanical Verification Testing conducted on the Devicor
Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] demonstrates that the subject device is as safe, as
effective, and performs as well as, the legally marketed predicate
device. This testing supports a determination of substantial
equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK®
Breast Biopsy Site Marker [subject device] when compared to the
Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site
Marker (K161021) [predicate device] and (K121113 and K130537)
[reference device]. |
| Overall Conclusion: The data generated from the results of the Non-Clinical Performance Bench Testing conducted on the Devicor
Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] demonstrate that the device is as safe, as effective, and | |
12
performs as well as, the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. Therefore, the data results may be relied on to support a determination of substantial equivalence (SE).
Human Factors/Usability Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to confirm the safety and effectiveness of the device for the intended users, uses, and use environments. The results of the Human Factors/Usability Testing confirmed that the subject device has been found to be safe and effective for the intended users, uses and use environments, and that the subject device and that it is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K12113 and K130537) [reference device]. The following Human Factors/Usability Testing data were provided in support of the substantial equivalence (SE) determination.
- Human Factors/Usability Testing
- Formative Studies (FE1) and (FE2)
The table below includes a high-level summary of the Human Factors/Usability Testing and Formative Studies data results submitted, referenced, or relied on in this premarket notification submission [510(k)] for a determination of substantial equivalence (SE).
| Human Factors/Usability Testing and Formative Studies | |
|---|---|
| Human Factors/Usability Testing Simulated Use Testing Formative Studies (FE1 and FE2) | Test Results: PASSED |
| The results of these Non-Clinical Bench Performance Data were provided in | |
| support of the substantial equivalence (SE) determination. | |
| FDA Recognized Testing Standards: | |
| IEC 62366-1:2015-Medical Devices, | |
| Part 1: Application of Usability | |
| Engineering to Medical Devices IEC 60601-1-6:2010 + A1:2013-Medical | |
| Electrical Equipment-Part 1-6: General | |
| Requirements for Basic Safety and | |
| Essential Performance-Collateral | |
| Standard: Usability | Conclusion Supporting Substantial Equivalence (SE): The results of the |
| Human Factors/Usability Testing and Formative Studies conducted on the | |
| Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker | |
| [subject device] demonstrates that the subject device is as safe, as | |
| effective, and performs as well as, the legally marketed predicate device. | |
| This testing supports a determination of substantial equivalence (SE) of the | |
| Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker | |
| [subject device] when compared to the Devicor Medical Products Inc. | |
| HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and | |
| (K121113 and K130537) [reference device]. |
13
K203097 p. 11 of 16
| • | FDA's Guidance Applying Human
Factors and Usability Engineering to
Optimize Medical Device Design (2016) |
|---|----------------------------------------------------------------------------------------------------------------------------|
| • | IEC 62366-2:2016-Medical Devices,
Part 2: Guidance on the Application of
Usability Engineering to Medical
Devices |
Biocompatibility Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The results of the Biocompatibility Testing confirmed the biological safety of the subject device and that it is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. The following Biocompatibility Data were provided in support of the substantial equivalence (SE) determination.
GLP Cytotoxicity (MEM Elution) Testing ●
The table below includes the list of the Biocompatibility Testing results submitted, referenced, or relied on in this premarket notification (510(k)) for a determination of substantial equivalence (SE).
| Summary of Biocompatibility Testing | ||
|---|---|---|
| Biocompatibility Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker | ||
| [subject device]. The table below includes the list of the performance testing results submitted, referenced, or relied on in | ||
| this premarket notification submission [510(k)] for a determination of substantial equivalence (SE). | ||
| Biocompatibility Testing (Cytotoxicity MEM Elution) | ||
| ● | Biocompatibility Testing including: | Test Results: PASSED |
| Cytotoxicity (MEM Elution) | ||
| Testing | The results of these Biocompatibility Data were provided in support of the | |
| substantial equivalence (SE) determination. | ||
| FDA Recognized Testing Standards: | ||
| Conclusion Supporting Substantial Equivalence (SE): | ||
| ● | ISO 10993-1:2018-Biological Evaluation | |
| of Medical Devices – Part 1: Evaluation | ||
| and Testing Within a Risk Management | ||
| Process | The results of the Biocompatibility Testing conducted on the Devicor | |
| Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject | ||
| device] demonstrates that the subject device is as safe, as effective, and | ||
| performs as well as, the legally marketed predicate device. This testing | ||
| ● | ISO 10993-5:2009-Biological Evaluation | |
| of Medical Devices – Part 5: Tests for In | ||
| Vitro Cytotoxicity | supports a determination of substantial equivalence (SE) of the Devicor | |
| Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject | ||
| device] when compared to the Devicor Medical Products Inc. HydroMARK® | ||
| ● | ISO 10993-10:2010-Biological | |
| Evaluation of Medical Devices – Part | ||
| 10: Tests for Irritation and Skin | ||
| Sensitization | Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and | |
| K130537) [reference device]. | ||
| ● | ISO 10993-11:2017-Biological | |
| Evaluation of Medical Devices – Part | ||
| 11: Tests for Systemic Toxicity |
Chemical Characterization Testing (including Exhaustive Extraction and Toxicological Risk Assessment) was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to assess potential toxicological risks of the device materials. The Chemical Characterization Testing confirmed no unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The results of the Chemical Characterization Testing
14
confirmed the biological safety of the subject device and that it is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. The following Biocompatibility Data were provided in support of the substantial equivalence (SE) determination.
| Summary of Chemical Characterization Testing | |
|---|---|
| Chemical Characterization Testing (including Exhaustive Extractables and Toxicological Risk Assessment) was conducted | |
| on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device]. The table below includes | |
| the list of the performance testing results submitted, referenced, or relied on in this premarket notification submission | |
| [510(k)] for a determination of substantial equivalence (SE). | |
| Exhaustive Extractables Testing | |
| Exhaustive Extractables Testing | Test Results: PASSED |
| The results of these Chemical Characterization Data were provided in | |
| support of the substantial equivalence (SE) determination. |
Conclusion Supporting Substantial Equivalence (SE):
The results of the Chemical Characterization Testing conducted on the
Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] demonstrates that the subject device is as safe, as
effective, and performs as well as, the legally marketed predicate device.
This testing supports a determination of substantial equivalence (SE) of the
Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] when compared to the Devicor Medical Products Inc.
HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and
(K121113 and K130537) [reference device]. |
| FDA Recognized Testing Standards: | |
| • ISO 10993-12:2012-Biological
evaluation of medical devices-Part 12:
Sample preparation and reference
materials. | |
| • ISO 10993-18:2020-Biological
evaluation of medical devices-Part 18:
Chemical characterization of medical
device materials within a risk
management process | |
| Toxicological Risk Assessment | |
| Toxicological Risk Assessment | Test Results: PASSED
The results of these Chemical Characterization Data were provided in
support of the substantial equivalence (SE) determination.
Conclusion Supporting Substantial Equivalence (SE):
The results of the Chemical Characterization Testing conducted on the
Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] demonstrates that the subject device is as safe, as
effective, and performs as well as, the legally marketed predicate device.
This testing supports a determination of substantial equivalence (SE) of the
Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] when compared to the Devicor Medical Products Inc.
HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and
(K121113 and K130537) [reference device]. |
| FDA Recognized Testing Standards: | |
| • ISO 10993-1:2018-Biological Evaluation
of Medical Devices - Part 1: Evaluation
and Testing Within a Risk Management
Process | |
| • ISO 10993-18:2020-Biological
evaluation of medical devices-Part 18:
Chemical characterization of medical
device materials within a risk
management process | |
| • ISO 10993-17:2002-Biological
evaluation of medical devices - Part 17:
Establishment of allowable limits for
leachable substances | |
Bioburden Testing, Sterilization Testing, Sterility Testing, Endotoxin Testing and Residual Analysis Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to confirm the sterility and shelf-life of the results of the Sterilization Testing, Bioburden Testing, and Endotoxin Testing and confirmed the sterility and safety of the subject device and that it is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K12113 and K130537) [reference device]. The following Sterilization Testing, Bioburden Testing, and Endotoxin Testing Data were provided in support of the substantial equivalence (SE) determination.
15
- Bioburden Testing
- Sterilization Testing
- Sterilization Load Configuration / Challenge Device Placements / Biological Indicator o Placements
- Sterility Testing ●
- Sterility Testing of the Natural Product O
- Sterility Testing of the Biological Indicators O
- Endotoxin Testing
- Residual Analysis Testing
Summary of the Bioburden Testing, Sterility Testing, Endotoxin Testing and Residual Analysis Testing Bioburden Testing, Sterilization Testing, Endotoxin Testing and Residual Analysis Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device]. The table below includes the list of the performance testing results submitted, referenced, or relied on in this premarket notification submission [510(k)] for a determination of substantial equivalence (SE). Bioburden Testing Test Results: PASSED Bioburden Testing ● The results of these Bioburden Testing Data were provided in support of FDA Recognized Testing Standards: the substantial equivalence (SE) determination. ANSI/AAMI/ISO 11737-1:2018 – . Conclusion Supporting Substantial Equivalence (SE): Sterilization of Health Care Products -The results of the Bioburden Testing conducted on the Devicor Medical Microbiological Methods-Part 1: Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] Determination of a Population of demonstrates that the subject device is as safe, as effective, and performs Microorganisms on Products. as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. Sterilization Testing Test Results: PASSED ● Sterilization Testing The results of these Sterilization Testing Data were provided in support of FDA Recognized Testing Standards: the substantial equivalence (SE) determination. ANSI/AAMI/ISO 11737-1:2018 – ● Conclusion Supporting Substantial Equivalence (SE): Sterilization of Health Care Products – Microbiological Methods-Part 1: The results of the Sterilization Testing conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] Determination of a Population of demonstrates that the subject device is as safe, as effective, and performs Microorqanisms on Products. as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. Sterility Testing of the Natural Product
| • Sterility Testing of the Natural Product
FDA Recognized Testing Standards: | Test Results: PASSED
The results of these Sterility Testing of the Natural Product Data were
provided in support of the substantial equivalence (SE) determination. | |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | ANSI/AAMI/ISO 11737-1:2018 -
Sterilization of Health Care Products –
Microbiological Methods-Part 1:
Determination of a Population of
Microorganisms on Products. | Conclusion Supporting Substantial Equivalence (SE):
The results of the Sterility Testing of the Natural Product conducted on the
Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] demonstrates that the subject device is as safe, as
effective, and performs as well as, the legally marketed predicate device.
This testing supports a determination of substantial equivalence (SE) of the
Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] when compared to the Devicor Medical Products Inc.
HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and
(K121113 and K130537) [reference device]. |
| • | Sterility Testing of the Biological Indicators
FDA Recognized Testing Standards:
• ANSI/AAMI/ISO 11737-1:2018 –
Sterilization of Health Care Products –
Microbiological Methods-Part 1:
Determination of a Population of
Microorganisms on Products. | Sterility Testing of the Biological Indicators
Test Results: PASSED
The results of these Sterility Testing of the Biological Indicators Data were
provided in support of the substantial equivalence (SE) determination.
Conclusion Supporting Substantial Equivalence (SE):
The results of the Sterility Testing of the Biological Indicators conducted on
the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] demonstrates that the subject device is as safe, as
effective, and performs as well as, the legally marketed predicate device.
This testing supports a determination of substantial equivalence (SE) of the
Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker
[subject device] when compared to the Devicor Medical Products Inc.
HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and
(K121113 and K130537) [reference device]. |
| • | Endotoxin Testing
FDA Recognized Testing Standards:
• USP Bacterial Endotoxins Testing
• ANSI/AAMI ST72: Bacterial Endotoxins
– Test Methods | Endotoxin Testing
Test Results: PASSED
The results of these Endotoxin Testing Data were provided in support of the
substantial equivalence (SE) determination.
Conclusion Supporting Substantial Equivalence (SE):
The results of the Endotoxin Testing conducted on the Devicor Medical
Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device]
demonstrates that the subject device is as safe, as effective, and performs
as well as, the legally marketed predicate device. This testing supports a
determination of substantial equivalence (SE) of the Devicor Medical
Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device]
when compared to the Devicor Medical Products Inc. HydroMARK® Breast
Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537)
[reference device]. |
| • | Residual Analysis Testing
FDA Recognized Testing Standards:
• USP Bacterial Endotoxins Testing
• ANSI/AAMI ST72: Bacterial Endotoxins
– Test Methods | Residual Analysis Testing
Test Results: PASSED
The results of these Residual Analysis Testing Data were provided in
support of the substantial equivalence (SE) determination.
Conclusion Supporting Substantial Equivalence (SE):
The results of the Residual Analysis Testing conducted on the Devicor
Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject
device] demonstrates that the subject device is as safe, as effective, and
performs as well as, the legally marketed predicate device. This testing
supports a determination of substantial equivalence (SE) of the Devicor
Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject
device] when compared to the Devicor Medical Products Inc. HydroMARK® |
| | Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and
K130537) [reference device]. | |
16
17
Shelf-Life Testing / Transit Verification Testing was conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] to confirm the twelve (12) Month and eighteen (18) Month Shelf-Life of the device. The results of the 12 Month Aging Testing / 18 Month Aging Testing confirmed the shelf-life of the subject device and that it is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. The following Shelf-Life Testing Data were provided in support of the substantial equivalence (SE) determination.
- . Shelf-Life / Transit Verification Testing (12 Month Aging) – Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing
- . Shelf-Life / Transit Verification Testing (12 Month Aging) – Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing
| Shelf-Life Testing / Transit Testing (12 Month Aging) - Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing | |
|---|---|
| Shelf-Life / Transit Verification Testing (12 Month Aging) – Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing FDA Recognized Testing Standards: ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ASTM F2095-11: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) ASTM F38/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials | Test Results: PASSED |
| The results of these Shelf-Life Testing (12 Month Aging) were provided in support of the substantial equivalence (SE) determination. |
Conclusion Supporting Substantial Equivalence (SE):
The results of the Shelf-Life Testing (12 Month Aging) conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. |
| Shelf-Life Testing / Transit Testing (18 Month Aging) - Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing | |
| Shelf-Life / Transit Verification Testing (18 Month Aging) – Climatic Conditioning, Packaging Performance, Gross Leak Detection (Bubble), and Seal Strength (Peel) Testing FDA Recognized Testing Standards: ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ASTM F2095-11: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) ASTM F38/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials | Test Results: PASSED
The results of these Shelf-Life Testing (18 Month Aging) were provided in support of the substantial equivalence (SE) determination.
Conclusion Supporting Substantial Equivalence (SE):
The results of the Shelf-Life Testing (18 Month Aging) conducted on the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence (SE) of the Devicor Medical Products, Inc. HydroMARK® Breast Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. |
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| Method for Seal Strength of Flexible
| Barrier Materials | |
|---|---|
| ----------------------------------------------------------- | -- |
IX. OVERALL CONCLUSIONS
The data generated from the results of the following testing conducted on the HydroMARK® Breast Biopsy Site Marker [subject device] demonstrate that the device is as safe, as effective, and performs as well as, the Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) [predicate device] and (K121113 and K130537) [reference device]. Therefore, these data results may be relied on to support a determination of substantial equivalence (SE).