(137 days)
No
The document describes a physical implantable marker and its delivery system. There is no mention of software, algorithms, or any form of data processing that would suggest the use of AI or ML. The focus is on material composition and mechanical design.
No
The device is described as a "Biopsy Site Marker" indicated to "mark tissue associated with a percutaneous breast biopsy procedure." Its purpose is to identify sites for future imaging, not to treat a disease or condition.
No
The device is a biopsy site marker, not a diagnostic tool. Its purpose is to mark tissue for future identification, not to provide diagnostic information about a medical condition.
No
The device description clearly states it is an implantable marker made of nitinol and supplied in a disposable applicator, indicating it is a physical medical device, not software.
Based on the provided information, the LumiMARK™ Biopsy Site Marker is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body.
- LumiMARK™ Function: The LumiMARK™ Biopsy Site Marker is an implantable device designed to be placed inside the body (specifically, in breast tissue or axillary lymph nodes) to mark a biopsy site. It is not used to analyze a specimen taken from the body.
- Intended Use: The intended use is to "mark tissue associated with a percutaneous breast biopsy procedure," not to perform a diagnostic test on a sample.
- Device Description: The description clearly states it is an "implant component" and is "permanently visible, implantable markers."
Therefore, the LumiMARK™ Biopsy Site Marker falls under the category of an implantable medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray, and MRI.
Product codes
NEU
Device Description
The LumiMARK™ Biopsy Site Marker implant component [subject device] is composed of a nitinol (nickel/titanium alloy) material versus HydroMARK™ Breast Biopsy Site Marker [predicate device] which is composed of titanium or stainless steel encapsulated in resorbable hydrogel. The marker is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that allows the marker to be inserted with direct puncture under ultrasound. The applicator system is of similar design and materials as the currently marketed Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].
LumiMARK™ Biopsy Site Markers will be available in three different shapes. These permanently visible, implantable markers will allow the physician to identify different biopsied sites under ultrasound, x-ray, and MRI. A similar marker device commercialized by Devicor Medical Products, Inc. is already available (under K212158), and this HydroMARK™ Breast Biopsy Marker [predicate].
The deployment system used for the LumiMARK™ Biopsy Site Marker device [subject] will be similar to the HydroMARK™ Breast Biopsy Site Marker [predicate] delivery system with minor design changes to the plunger assembly and cannula. The nitinol markers will be intended for direct puncture or insertion through another introducer needle that is already in the breast or axillary lymph node.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, x-ray, and MRI.
Anatomical Site
tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes
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
Summary of Performance Testing:
Performance Testing was conducted on the Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] to confirm that the device meets all system requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K212158) [predicate device].
Test Results: PASSED. The results of all performance testing met acceptance criteria and are provided in support of the substantial equivalence determination.
LumiMARK™ Risk Management Results: All risks have been reduced as far as possible through allowed controls: Inherent safety by design, information for safety, and/or preventative measures. There are no unacceptable residual risks at this time. The overall residual risk arising from individual and cumulative risk is acceptable. Benefits outlined are greater than the risks. The product is considered State-of-the-Art.
Conclusion Supporting Substantial Equivalence: The results of the design verification carried out within Devicor Medical Product's ISO 13485:2016 compliant Quality Management System conducted on the LumiMARK™ Biopsy Site Marker [subject device] demonstrates that the subject device is as safe and as effective as the legally marketed predicate device. This evidence in conjunction with the ISO 14971:2019 compliant Risk Management process supports a determination of substantial equivalence of the Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] when compared to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate devices].
Biocompatibility Testing:
Test Results: PASSED. The results of these Non-Clinical Bench Performance Data are provided in support of the substantial equivalence determination.
Conclusion Supporting Substantial Equivalence: 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 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 (K212158) [predicate device].
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2024
Devicor Medical Products, Inc. Katy Austin Regulatory Affairs Specialist 300 E-Business Way, Fifth Floor Cincinnati. Ohio 45241
Re: K232615
Trade/Device Name: LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: August 28, 2023 Received: December 15, 2023
Dear Katy Austin:
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.
2
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, Tek N. Lamichhane -Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232615
Device Name
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))
Indications for Use (Describe)
The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray, and MRI.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary-K232615
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.
Katy Austin, Senior Regulatory Affairs Specialist Email: katy.austin@mammotome.com
Date Prepared
January 12, 2024
DEVICE [Per 807.92(a)(2)]
| Device Trade/Proprietary Name: | LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)) |
|---|---|
| LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)) | |
| LumiMARK™ Biopsy Site Marker (LM0215R (Rose Shape)) | |
| Regulation Description | Implantable Marker |
| Device Common or Usual Name: | Marker, Radiographic, Implantable |
| Device Regulatory Classification: | Class II |
| Device Classification Regulation: | 21 CFR §878.4300 |
| Product Code: | (NEU) – Marker, Radiographic, Implantable |
| Submission Type: | Traditional 510(k) Premarket Notification |
| Classification Panel: | General & Plastic Surgery |
| Premarket Review: | Surgical and Infection Control Devices (OHT4) |
| Infection Control and Plastic Surgery Devices (DHT4B) |
PREDICATE DEVICE [Per 807.92(a)(3)]
| | The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] is
substantially equivalent (SE) to the Sponsor's own predicate devices: |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | •
Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker
(K212158) [predicate device] |
| Predicate
Device | The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] is
substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast
Biopsy Site Marker (K212158) [predicate device] in terms of similar Indications for Use
/ Intended Use to mark tissue during or associated with a percutaneous breast biopsy
procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible
by x-ray and MRI. The Devicor Medical Product, Inc. LumiMARK™ Biopsy Site Marker |
5
| (subject device) includes axillary lymph nodes in the Indications for Use/Intended Use
statement as a direct puncture device, also demonstrated in HydroMARK™ as cleared
| in K212158. |
|---|
| • Substantial equivalence (SE) of the subject device is based on substantially |
| equivalent design, functionality, and performance characteristics as the |
| predicate device. |
DEVICE DESCRIPTION [Per 807.92(a)(4)]
The LumiMARK™ Biopsy Site Marker implant component [subject device] is composed of a nitinol (nickel/titanium alloy) material versus HydroMARK™ Breast Biopsy Site Marker [predicate device] which is composed of titanium or stainless steel encapsulated in resorbable hydrogel. The marker is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that allows the marker to be inserted with direct puncture under ultrasound. The applicator system is of similar design and materials as the currently marketed Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].
LumiMARK™ Biopsy Site Markers will be available in three different shapes. These permanently visible, implantable markers will allow the physician to identify different biopsied sites under ultrasound, x-ray, and MRI. A similar marker device commercialized by Devicor Medical Products, Inc. is already available (under K212158), and this HydroMARK™ Breast Biopsy Marker [predicate].
The deployment system used for the LumiMARK™ Biopsy Site Marker device [subject] will be similar to the HydroMARK™ Breast Biopsy Site Marker [predicate] delivery system with minor design changes to the plunger assembly and cannula. The nitinol markers will be intended for direct puncture or insertion through another introducer needle that is already in the breast or axillary lymph node.
| Product Code | Description | Shape |
|---|---|---|
| LM0215T | LumiMARK Biopsy Site Marker "Tulip shape" | Image: Tulip shape marker |
| LM0215L | LumiMARK Biopsy Site Marker "Lotus shape" | Image: Lotus shape marker |
| LM0215R | LumiMARK Biopsy Site Marker "Rose shape" | Image: Rose shape marker |
This Traditional 510(k) is being submitted to introduce LumiMARK™ Biopsy Siter Markers to the marketplace as part of the Mammotome brand, and the fundamental scientific technology when compared to the HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] has not changed. Both subject and predicate will have 3 year/36 month shelf life.
A User Instructions & Operations Guide, and Safety Information Booklet will be provided for all LumiMARK™ Biopsy Site Markers.
6
INDICATIONS FOR USE
[Per 807.92(a)(5)
The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray and MRI.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]
The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] based on the similar functional and performance characteristics of the subject device when compared to the predicate device. The minor differences between the subject device and predicate device do not raise concerns of safety and effectiveness.
A side-by-side comparison of the technological characteristics of the subject device and the predicate device, supports a determination of substantial equivalency (SE) per the table below.
| LumiMARK Comparison to Predicate HydroMARK Breast Biopsy Site Marker (K212158) | |||
|---|---|---|---|
| Regulatory | |||
| Information | Project Nike | ||
| LumiMARK™ Biopsy | |||
| Site Marker [subject] | HydroMARK™ Breast | ||
| Biopsy Site Marker | |||
| K212158 | Comparison | ||
| Manufacturer | Devicor Medical Products | ||
| De Mexico S De RL De CV | Devicor Medical Products | ||
| De Mexico S De RL De CV | --- | ||
| Device Trade or | |||
| Proprietary | |||
| Name | LumiMARK™ Biopsy Site | ||
| Marker | HydroMARK™ Breast | ||
| Biopsy Site Marker | --- | ||
| 510(k) Number | K232615 | K212158 | N/A |
| Device Class | Class II | Class II | Substantially Equivalent |
| Device | |||
| Classification | |||
| Name | Marker, Radiographic, | ||
| Implantable | Marker, Radiographic, | ||
| Implantable | Substantially Equivalent | ||
| Device Common | |||
| Name | Implantable Marker | Implantable Marker | Substantially Equivalent |
| Product Code | (NEU) — Marker, | ||
| Radiographic, Implantable | (NEU) — Marker, | ||
| Radiographic, Implantable | Substantially Equivalent | ||
| Regulation | |||
| Number | 21 CFR §878.4300 | 21 CFR §878.4300 | Substantially Equivalent |
7
| Design Features and Capabilities of the Device | |||
|---|---|---|---|
| Indications for | |||
| Use | To mark tissue associated | ||
| with a percutaneous breast | |||
| biopsy procedure, including | |||
| axillary lymph nodes, and be | |||
| permanently visible under | |||
| ultrasound, x-ray and MRI. | To mark tissue during a | ||
| percutaneous breast | |||
| biopsy procedure, | |||
| including axillary lymph | |||
| nodes, be visible under | |||
| ultrasound for at least 6 | |||
| weeks, and be | |||
| permanently visible by x- | |||
| ray and MRI. | Substantially Equivalent | ||
| Prescription or | |||
| Over-the- | |||
| Counter (OTC) | |||
| Use | Prescription | Prescription | Substantially Equivalent |
| Use Environment | |||
| Sterile | Yes | Yes | Same |
| Single-Use | Yes | Yes | Same |
| Design Features | |||
| Marker Material | Nitinol (50% Nickel, 50% | ||
| Titanium) | Stainless Steel or Titanium | ||
| marker, surrounded by | |||
| hydrogel | Substantially Equivalent | ||
| Marker Shape | Tulip (LM0215T) | ||
| Lotus (LM0215L) | |||
| Rose (LM0215R) | Barrel (T1, S1) | ||
| Butterfly (T4) | |||
| Open Coil (T3, S3) | Substantially Equivalent | ||
| Cannula Type | Rigid | Rigid | Substantially Equivalent |
| Cannula | |||
| Material | Stainless Steel | Stainless Steel | Substantially Equivalent |
| Plunger Rod | |||
| Material | Stainless Steel | Stainless Steel | Substantially Equivalent |
| Plastic Handle | Plastic Polymer | Plastic Polymer | Substantially Equivalent |
| Plunger Lock | P Plastic Polymer | Plastic Polymer | Substantially Equivalent |
| Plastic Plunger | |||
| Button | Plastic Polymer | Plastic Polymer | Substantially Equivalent |
| Shelf Life | 3 years/36 months | 3 years/36 months | Substantially Equivalent |
| Biocompatibility | |||
| results | - Chemical | ||
| Characterization | |||
| Cytotoxicity | |||
| Sensitization | |||
| Irritation | |||
| Acute Systemic | |||
| Toxicity | |||
| Pyrogenicity | |||
| Subacute/ Chronic/ | |||
| Subchronic Toxicity | |||
| Implantation | |||
| Genotoxicity | |||
| Carcinogenicity | - Chemical | ||
| Characterization | |||
| Cytotoxicity | |||
| Sensitization | |||
| Irritation | |||
| Acute Systemic | |||
| Toxicity | |||
| Pyrogenicity | |||
| Subacute/ Chronic/ | |||
| Subchronic Toxicity | |||
| Implantation | |||
| Genotoxicity | |||
| Carcinogenicity | Substantially Equivalent | ||
| Performance | |||
| evaluation | - Marker Size | ||
| Deployment Force | |||
| Visibility | - Marker Size | ||
| Deployment Force | |||
| Visibility | Substantially Equivalent |
8
| MR Testing Results | |||
|---|---|---|---|
| MR Status for | |||
| Marker | MR Conditional | MR Conditional | Substantially Equivalent |
| MR Status for | |||
| Applicator | MR Unsafe | MR Unsafe | Substantially Equivalent |
SUMMARY OF VERIFICATION DATA AND VERIFICATION TEST CONCLUSIONS [Per 807.92(b)(1)(2)(3)]
Summary of Performance Testing
Performance Testing was conducted on the Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] to confirm that the device meets all system requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K212158) [predicate device]. The following Verification Data was provided in support of the substantial equivalence (SE) determination.
| Performance Testing | |
|---|---|
| Performance Testing LumiMARK™ | Test Results: PASSED |
| The results of all performance testing met acceptance criteria | |
| and are provided in support of the substantial equivalence | |
| determination. | |
| LumiMARK™ Risk Management | Results: All risks have been reduced as far as possible |
| through allowed controls: Inherent safety by design, | |
| information for safety, and/or preventative measures. | |
| There are no unacceptable residual risks at this time. The | |
| overall residual risk arising from individual and cumulative | |
| risk is acceptable. Benefits outlined are greater than the | |
| risks. The product is considered State-of-the-Art. | |
| ● FDA Recognized Testing Standards: | |
| ○ ISO 13485:2016 | |
| Certification - Medical Devices – | |
| Quality Management Systems – | |
| Requirements for Regulatory Purposes | |
| process for medical devices | |
| ○ ISO 14971:2019 (Ed.3.0) | |
| – Medical Devices - Application of Risk | |
| Management to Medical Devices | Conclusion Supporting Substantial Equivalence: The results |
| of the design verification carried out within Devicor Medical | |
| Product's ISO 13485:2016 compliant Quality Management | |
| System conducted on the LumiMARK™ Biopsy Site Marker | |
| [subject device] demonstrates that the subject device is as | |
| safe and as effective as the legally marketed predicate | |
| device. This evidence in conjunction with the ISO 14971:2019 | |
| compliant Risk Management process supports a | |
| determination of substantial equivalence of the Devicor | |
| Medical Products, Inc. LumiMARK™ Biopsy Site Marker | |
| [subject device] when compared to the Devicor Medical | |
| Products Inc. HydroMARK™ Breast Biopsy Site Marker | |
| (K212158) [predicate devices]. |
9
| Biocompatibility Testing including: | Biocompatibility Testing |
|---|---|
| Chemical Characterization Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Material-Mediated Pyrogenicity Subacute/Subchronic/ Chronic Toxicity Implantation Effects Genotoxicity Carcinogenicity | Test Results: PASSED |
| The results of these Non-Clinical Bench Performance Data are provided in | |
| support of the substantial equivalence determination. | |
| FDA Recognized Testing Standards: | Conclusion Supporting Substantial Equivalence: |
| ISO 10993-1:2018-Biological | |
| Evaluation of Medical Devices – Part 1: | |
| Evaluation and Testing Within a Risk | |
| Management Process ISO 10993-3:2014 Biological | |
| Evaluation of Medical Devices – Part 3: | |
| Tests for Genotoxicity, carcinogenicity | |
| and reproductive toxicity ISO 10993-5:2009-Biological | |
| Evaluation of Medical Devices – Part 5: | |
| Tests for In Vitro Cytotoxicity ISO 10993-6:2016-Biological | |
| Evaluation of Medical Devices – Part 6: | |
| Tests for local effects after | |
| implantation ISO 10993-10:2010-Biological | |
| Evaluation of Medical Devices – Part | |
| 10: Tests for Irritation and Skin | |
| Sensitization ISO 10993-11:2017-Biological | |
| Evaluation of Medical Devices – Part | |
| 11: Tests for Systemic Toxicity ISO 10993-17:2002 Biological | |
| Evaluation of Medical Devices – Part | |
| 17: Establishment of allowable limits | |
| for leachable substances ISO 10993-18:2020 Biological | |
| Evaluation of Medical Devices – Part | |
| 18: Chemical characterization of | |
| medical device materials within a risk | |
| management process ISO 10993-23:2021 Biological | |
| Evaluation of Medical Devices – Part | |
| 23: Tests for Irritation | 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 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 | |
| (K212158) [predicate device]. | |
| Conclusion: The results of the Verification Testing support the safety of the device and demonstrate that the |
requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].
10
SUBSTANTIAL EQUIVALENCE SUMMARY / CONCLUSIONS
Based on the verification results and a side-by-side comparison of the technological characteristics of design, indication for use / intended use, components, and materials of construction, it is concluded that the Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker (K232615) [subject device] is substantially equivalent to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].