Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles

Q: Who is the manufacturer of Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles?

Promisemed Hangzhou Meditech Co., Ltd. filed the 510(k) submission for Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (K210946).

Q: What is the FDA product code for Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K210946 · Promisemed Hangzhou Meditech Co., Ltd. · KNW · Aug 12, 2021 · Gastroenterology, Urology

Device Facts

Record ID	K210946
Device Name	Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
Applicant	Promisemed Hangzhou Meditech Co., Ltd.
Product Code	KNW · Gastroenterology, Urology
Decision Date	Aug 12, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended 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.

Device Story

Hand-operated, non-electronic surgical instruments for soft tissue biopsy. Automatic needles use spring-loaded mechanism to extract specimens; semi-automatic needles require manual advancement of inner needle followed by spring-actuated cutting cannula. Co-axial devices guide needle insertion under imaging (ultrasound, X-ray, CT). Used in clinical settings by physicians. Devices are sterile, single-use, and non-MRI compatible. Output is a tissue specimen for pathological examination. Benefits include minimally invasive tissue acquisition for diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included ISO 9626 compliance for needle tubing and comprehensive biocompatibility testing (ISO 10993-1, -5, -7, -10, -11) and pyrogenicity (USP <151>).

Technological Characteristics

Materials: 304 stainless steel (X5CrNi18-10). Energy source: Mechanical spring-loaded. Form factor: Hand-held needles/cannulas. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring biopsy sampling of soft tissues (liver, kidney, prostate, breast, lymph nodes, soft tissue tumors). Not for use in bone. Breast biopsy use is for diagnosis only.

Regulatory Classification

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.

Predicate Devices

MEDONE ULTRA Soft tissue programmable automatic disposable biopsy system (K192101)
VELOX 2 Biopsy Needle (K181803)
Perineologic Access Needle (K160423)

Related Devices

K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle · Canyon Medical, Inc. · Apr 3, 2023
K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle · Canyon Medical, Inc. · Jan 17, 2024
K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 24, 2025
K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit · Bard Peripheral Vascular, Inc. · Jul 10, 2025
K162588 — Möller Medical Biopsy Needles and Systems · Moller Medical GmbH · Jun 19, 2017

Submission Summary (Full Text)

{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) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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." {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<151> 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.