(135 days)
Not Found
No
The device description explicitly states that the devices are "hand-operated, non-electronic, surgical instruments" and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The devices are intended for obtaining biopsy samples for diagnosis, not for treating a condition.
Yes
The device obtains biopsy samples for 'tissue pathological examination/testing', and for breast biopsy specifically, it is stated to be 'for diagnosis only', directly indicating its role in the diagnostic process.
No
The device description explicitly states that the devices are "hand-operated, non-electronic, surgical instruments" and describes mechanical actions (springs, manual advancement). There is no mention of software as a component or function of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described devices (Automatic Biopsy Needles, Semi-automatic Biopsy Needles, and Co-Axial Biopsy Device) are instruments used to obtain tissue samples from the body. They are tools for the collection of the sample, not for the analysis or testing of the sample itself.
- Intended Use: The intended use clearly states that the devices are for "obtaining biopsy samples from soft tissues" and for "guiding the insertion of biopsy needle." The subsequent analysis of these samples would be performed using IVD methods, but the biopsy needle itself is not an IVD.
- Device Description: The description details the mechanical operation of the needles for tissue extraction. It does not describe any components or processes related to the in vitro analysis of a sample.
In summary, these devices are surgical instruments used for tissue collection, which is a step that precedes in vitro diagnostic testing. They are not the diagnostic tests themselves.
N/A
Intended Use / Indications for Use
Automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Co-Axial Biopsy Device is mainly used to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is not intended for use in bone.
Semi-automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.
Product codes
KNW, FCG
Device Description
Promisemed Automatic Biopsy Needles, Semi-automatic Biopsy Needles and Co-axial Biopsy Devices are hand-operated, non-electronic, surgical instruments.
Promisemed Automatic Biopsy Needles is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Push the outer needle backward to expose the sampling slot of the inner needle by compression spring, then the spring's resilience realizes the movement of the outer needle and the excitation function.
Promisemed Semi-automatic Biopsy Needles is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.
Promisemed Co-Axial Biopsy Device is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip stylet.
Promisemed biopsy device and accessories are sterile with a Sterility Assurance Level (SAL) of 106, non-pyrogenic and single-use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, X-ray, CT
Anatomical Site
soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
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)
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. Other tests include:
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- d. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- e. ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
- f. USP42-NF37 Pyrogen Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
August 12, 2021
Promisemed Hangzhou Meditech Co., Ltd. % Ms. Wei-Shan Hsu Regulatory Manager Vee Care (Asia) Limited 1 7F Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, China
Re: K210946
Trade/Device Name: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-Automatic Biopsy Needles
Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: May 5, 2021 Received: June 21, 2021
Dear Ms. Wei-Shan Hsu:
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/cfpm/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.
1
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 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 (OS) 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 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/cdrl-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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General 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) K210946
Device Name Promisemed Automatic Biopsy Needles Promisemed Co-Axial Biopsy Devices Promisemed Semi-automatic Biopsy Needles
Indications for Use (Describe)
Automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Co-Axial Biopsy Device is mainly used to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is not intended for use in bone.
Semi-automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.
| 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) |
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3
510(k) Summary
Date Prepared ー
Aug 5th , 2021
2 Submitter's Information
Submission Sponsor:
Name: Promisemed Hangzhou Meditech Co., Ltd.
Address:No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, China
Contact Name: Mr. Zearou Yang, Regulatory Affairs Manager
Telephone No.: +86 571 88772985
Fax No.: +86 571 88772985
Email Address: zearou.yang@promisemed.ca
Submission Correspondent:
Name: Vee Care (Asia) Limited
Address: 17F Chung Pont Commercial Building, 300 Hennessy Road, Hong
Kong,China
Contact Name: Ms. Wei-Shan Hsu, Regulatory manager
Telephone No.: +852 2893 0833
E-mail: ws@vee.com.hk
ന Trade Name, Common Name, Classification
Trade/Product Name: Promisemed Automatic Biopsy Needles
Promisemed Co-Axial Biopsy Devices
Promisemed Semi-automatic Biopsy Needles
Common Name: Biopsy Devices and Accessories
Classification name: Gastroenterology-urology-biopsy instrument
Regulation Number: 21 CFR 876.1075
Device Class: Class II
Product Code: KNW, FCG
4
ldentification of Predicate Devices ব
- K192101: MEDONE ULTRA Soft tissue programmable automatic disposable biopsy system
K181803: VELOX 2 Biopsy Needle
K160423: Perineologic Access Needle
ഗ Description of the Device
Promisemed Automatic Biopsy Needles, Semi-automatic Biopsy Needles and Co-axial Biopsy Devices are hand-operated, non-electronic, surgical instruments.
Promisemed Automatic Biopsy Needles is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Push the outer needle backward to expose the sampling slot of the inner needle by compression spring, then the spring's resilience realizes the movement of the outer needle and the excitation function.
Promisemed Semi-automatic Biopsy Needles is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.
Promisemed Co-Axial Biopsy Device is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip stylet.
Promisemed biopsy device and accessories are sterile with a Sterility Assurance Level (SAL) of 106, non-pyrogenic and single-use devices.
The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These products can't be used under MRI.
5
Indication く
Automatic biopsy needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Co-Axial Biopsy Device is mainly used to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is not intended for use in bone.
Semi-automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.
Similarities and Differences of the Proposed Devices to the 7 Predicate Devices
The Promisemed Biopsy Devices and Accessories are substantially equivalent to the predicate devices in terms of intended use and technological characteristics. The differences above between the subject devices and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject device. Equivalence has been identified as follows:
| Subject device | Predicate Device |
|---|---|
| Promisemed Automatic | |
| Biopsy Needle | K192101 MEDONE ULTRA Soft tissue programmable |
| automatic disposable biopsy system | |
| Promisemed Semi- | |
| automatic Biopsy Needle | K181803 VELOX 2 Biopsy Needle |
| Promisemed Co-Axial Biopsy | |
| device | K160423 Perineologic Access Needle |
6
| | Subject Device | Predicate Device
(K192101) | Comments |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Trade Name | Promisemed Automatic
Biopsy Needle | Medax MEDONE ULTRA | |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | MEDAX S.R.L.
UNIPERSONALE | |
| Device Class | Class II | Class II | Same |
| Product Code | KNW | KNW | Same |
| Regulation number | 876.1075 | 876.1075 | Same |
| Regulation Name | Gastroenterology-
Urology Biopsy
Instrument | Gastroenterology-
Urology Biopsy
Instrument | Same |
| Device Description | Disposable
programmable
automatic spring-
loaded guillotine style
biopsy system for
histological biopsy on
soft tissue. | Disposable
programmable
automatic spring-
loaded guillotine style
biopsy system for
histological biopsy on
soft tissue. | Same |
| Intended Use/
Indications for Use | Automatic biopsy
needles are intended in
obtaining biopsy
samples from soft
tissues such as liver,
kidney, prostate,
breast, lymph nodes
and various soft tissue
tumors. It is not
intended for use in
bone. | Medax MEDONE ULTRA
intended for use in
obtaining core biopsy
samples from soft
tissue such as kidney,
liver, prostrate, spleen,
lymph nodes, and
various soft tissue
masses. Not intended
for use in bone. | Same |
| Target Population | Individuals requiring
biopsy for sampling of
soft tissue
abnormalities | Individuals requiring
biopsy for sampling of
soft tissue
abnormalities | Same |
| Mechanics of
Operation | Single hand automatic
activation | Single hand automatic
activation | Same |
| Gauge | 12G-20G | 14G-20G | Different
The subject
device has
smaller gauge
than predicate
device |
| Needle Length | 90mm-200mm | 60 mm to 200 mm | Different
The range of
needle length in |
| | | | subject device is
within that of
predicate device. |
| Patient/Tissue
Contact Material | Inner needle and outer
needle are made out of
304 stainless steel
(X5CrNi18-10).
Only Stainless steel is in
direct surgical contact
with all soft tissues of
the patient. | Cannula and mandrel
are made out of AISI
304 stainless steel.
Only Stainless steel is in
direct surgical contact
with all soft tissues of
the patient. | Same |
| Performance | Complied with ISO 9626 | Complied with ISO 9626 | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Biocompatible
according to ISO 10993
applicable parts | Biocompatible
according to ISO 10993
applicable parts | Same |
Table 1. Comparison of the Promisemed Automatic Biopsy Needle to the predicate device.
7
Table 2: Comparison of the Promisemed Semi-automatic Biopsy Needle to the predicate device.
| | Subject Device | Predicate Device
(K181803) | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Trade Name | Promisemed Semi-
automatic Biopsy
Needle | MEDEXTRA | Comments |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | MEDAX S.R.L.
UNIPERSONALE | |
| Device Class | Class II | Class II | Same |
| Product Code | KNW | KNW | Same |
| Regulation number | 876.1075 | 876.1075 | Same |
| Regulation Name | Gastroenterology-
Urology Biopsy
Instrument | Gastroenterology-
Urology Biopsy
Instrument | Same |
| Device Description | Disposable semi-
automatic spring
loaded guillotine style
biopsy system with
adjustable penetration
depth for histological
biopsy on soft tissue. | Disposable semi-
automatic spring
loaded guillotine style
biopsy system with
adjustable penetration
depth for histological
biopsy on soft tissue. | Same |
| Intended
Use/
Indications for Use | Semi-automatic biopsy
needles are intended in
obtaining biopsy
samples from soft | The device is intended
for use in obtaining
biopsies from soft
tissues such as liver | Same |
8
| | tissues such as liver,
kidney, prostate,
breast, lymph nodes
and various soft tissue
tumors. It is not
intended for use in
bone. | kidney, prostate,
breast, spleen, lymph
nodes and various soft
tissue masses. It is not
intended for use in
bone biopsy. | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Target Population | Individuals requiring
biopsy for sampling of
soft tissue
abnormalities | Individuals requiring
biopsy for sampling of
soft tissue
abnormalities | Same |
| Mechanics of
Operation | Single hand automatic
activation | Single hand automatic
activation | Same |
| Gauge | 14G-20G | 14G-20G | Same |
| Needle Length | 90mm-220mm | 80 mm to 300 mm | Different
The range of
needle length in
subject device is
within that of
predicate device. |
| Patient/Tissue
Contact Material | Inner needle and outer
needle are made out of
304 stainless steel
(X5CrNi18-10).
Only Stainless steel is in
direct surgical contact
with all soft tissues of
the patient. | Cannula and mandrel
are made out of AISI
304 stainless steel.
Only Stainless steel is
in direct surgical
contact with all soft
tissues of the patient. | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Biocompatible
according to ISO 10993
applicable parts | Biocompatible
according to ISO 10993
applicable parts | Same |
Table 3: Comparison of the Promisemed Co-Axial Biopsy Device to the predicate device.
| | Subject Device | Predicate Device
(K160423) | |
|--------------|------------------------------------------------|-----------------------------------|----------|
| Trade Name | Promisemed Semi-
automatic Biopsy
Needle | Perineologic Access
Needle | Comments |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Corbin Clinical
Resources, LLC | |
| Device Class | Class II | Class II | Same |
9
| Product Code | FCG | FCG | Same |
|---|---|---|---|
| Regulation number | 876.1075 | 876.1075 | Same |
| Regulation Name | Gastroenterology- | ||
| Urology Biopsy | |||
| Instrument | Gastroenterology- | ||
| Urology Biopsy | |||
| Instrument | Same | ||
| Intended Use/ | |||
| Indications for Use | Co-axial biopsy device | ||
| is mainly used to guide | |||
| the insertion of biopsy | |||
| needle into the soft | |||
| tissue under imaging | |||
| control (ultrasound, X- | |||
| ray, CT, etc.). It is not | |||
| intended for use in | |||
| bone. | The Perineologic Access | ||
| Needle is intended for | |||
| use as a guiding needle | |||
| in obtaining core biopsy | |||
| samples from soft | |||
| tissue and tumors of | |||
| such organs as liver, | |||
| kidney, spleen, lymph | |||
| nodes, prostate, lung | |||
| and various soft tissue | |||
| lesions. | Same | ||
| Target Population | Individuals requiring | ||
| biopsy for sampling of | |||
| soft tissue | |||
| abnormalities | Individuals requiring | ||
| biopsy for sampling of | |||
| soft tissue | |||
| abnormalities | Same | ||
| Gauge | 11G-19G | 14G-20G | Different |
| The subject | |||
| device has | |||
| smaller gauge | |||
| than predicate | |||
| device. | |||
| Needle Length | 60mm-190mm | 70 mm to 200 mm | Different |
| The subject | |||
| device has | |||
| shorter needle | |||
| length than | |||
| predicate device. | |||
| Device Type | Trocar tip stylet with/ | ||
| without blunt tip stylet | Trocar tip stylet | Different | |
| Subject device | |||
| has blunt tip | |||
| stylet as an | |||
| option to | |||
| minimize the risk | |||
| of unintentional | |||
| damage to target | |||
| tissue. | |||
| Visualization | |||
| Technique | Conventional imaging | ||
| guidance equipment | |||
| excluding MRI | Conventional imaging | ||
| guidance equipment | |||
| excluding MRI | Same | ||
| Needle Material | Stainless steel | Stainless steel | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | |||
| Biocompatible | |||
| according to ISO 10993 | |||
| applicable parts | Biocompatible | ||
| according to ISO 10993 | |||
| applicable parts | Same |
10
Performance Testing Summary 8
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. Other tests include:
- · ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- d. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- e. ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
- f. USP42-NF37 Pyrogen Test
の Conclusion
Based on the information provided within this 510(k) submission, proposed Promisemed Biopsy Devices and Accessories are substantially equivalent to the predicate devices and are as safe, as effective and perform as well as the legally marketed predicate devices.