(135 days)
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.
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.
This document describes a 510(k) premarket notification for Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, and Promisemed Semi-automatic Biopsy Needles. It does not present a study proving the device meets acceptance criteria in the way an AI/ML device would, but rather demonstrates substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and performance testing.
Therefore, many of the requested criteria for an AI/ML device's performance study (such as expert reads, MRMC studies, training/test set details, and ground truth establishment methods) are not applicable to this type of medical device submission.
Here's how to interpret the provided information in the context of the prompt, focusing on what is available and explaining why certain information is absent:
1. A table of acceptance criteria and the reported device performance
The document doesn't define "acceptance criteria" in terms of clinical performance metrics (like sensitivity/specificity for a diagnostic AI). Instead, for a medical device like a biopsy needle, "performance" is demonstrated through bench testing and adherence to recognized standards, showing that the device functions as intended and is safe and effective compared to similar devices already on the market.
The comparison tables for each device vs. its predicate device serve as the primary "performance" demonstration in this submission. The "Comments" column often highlights where the subject device either matches or has minor, acceptable differences from the predicate.
For example, from Table 1 (Promisemed Automatic Biopsy Needle vs. K192101):
| Feature / Criteria (Implicit) | Subject Device Performance (Reported) | Comments (Implying Acceptance) |
|---|---|---|
| Device Class | Class II | Same |
| Product Code | KNW | Same |
| Regulation Number/Name | 876.1075 / Gastroenterology-Urology Biopsy Instrument | Same |
| Device Description | Disposable programmable automatic spring-loaded guillotine style biopsy system for histological biopsy on soft tissue. | Same |
| Intended Use/Indications for Use | For obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. Not intended for use in bone. | Same |
| Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same |
| Mechanics of Operation | Single hand automatic activation | Same |
| Gauge | 12G-20G | Different; Subject device has smaller gauge than predicate device (implicitly accepted as within functional range and safe). |
| Needle Length | 90mm-200mm | Different; Range of needle length in subject device is within that of predicate device (implicitly accepted). |
| Patient/Tissue Contact Material | 304 stainless steel | Same |
| Performance | Complied with ISO 9626 | Same |
| Sterilization | EO Sterilization | Same |
| Single Use | Yes | Same |
| Biocompatibility | Biocompatible according to ISO 10993 applicable parts | Same |
The "Performance Testing Summary" on page 10 reiterates that "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." This is the core "proof" point for this type of submission.
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This is not a study involving a test set of patient data for an algorithm. The "testing" refers to mechanical and material property bench tests of the physical device. The documents do not specify sample sizes (e.g., number of needles tested) for the bench tests, as this is typically reported in standard engineering reports.
- Data Provenance (country of origin, retrospective/prospective): Not applicable, as no patient data is used in this type of submission for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. This device is a physical instrument, not an AI that interprets images or data requiring expert-established ground truth. The "ground truth" for a biopsy needle's performance is its physical characteristics (e.g., strength, sharpness, sterility) and its ability to procure tissue, as validated through engineering and biocompatibility testing against established standards (e.g., ISO standards).
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no human interpretation of a "test set" in the context of this device's performance validation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable. This is not an AI/ML device and therefore no MRMC studies are performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For this type of device, the "ground truth" is established by engineering specifications, material standards (e.g., stainless steel properties), and biological safety standards (e.g., ISO 10993 for biocompatibility, sterility assurance levels). The device's performance is compared against these industry-recognized benchmarks and the performance of legally marketed predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. There is no training set.
Summary regarding the study:
The provided document, a 510(k) Premarket Notification, demonstrates the substantial equivalence of Promisemed's biopsy devices to legally marketed predicate devices. The "study" proving the device meets acceptance criteria in this context consists of:
- Bench Testing: Verifying critical performance characteristics (e.g., mechanical properties, material composition, sterile attributes) against recognized international standards (e.g., ISO 9626:2016 for needle tubing, ISO 10993 for biocompatibility, USP42-NF37 <151> for pyrogenicity).
- Comparison Tables (Tables 1-3): Detailed comparisons of crucial technical specifications (e.g., gauge, needle length, materials, sterilization method, intended use) between the subject devices and their respective predicate devices. Any differences are explicitly noted and deemed not to affect the device's safety or effectiveness.
This approach is standard for demonstrating substantial equivalence for general medical devices, which differs significantly from the performance validation required for AI/ML-based medical devices.
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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.
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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
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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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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
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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 AutomaticBiopsy Needle | K192101 MEDONE ULTRA Soft tissue programmableautomatic disposable biopsy system |
| Promisemed Semi-automatic Biopsy Needle | K181803 VELOX 2 Biopsy Needle |
| Promisemed Co-Axial Biopsydevice | K160423 Perineologic Access Needle |
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| Subject Device | Predicate Device(K192101) | Comments | |
|---|---|---|---|
| Trade Name | Promisemed AutomaticBiopsy Needle | Medax MEDONE ULTRA | |
| Manufacturer | Promisemed HangzhouMeditech 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 BiopsyInstrument | Gastroenterology-Urology BiopsyInstrument | Same |
| Device Description | Disposableprogrammableautomatic spring-loaded guillotine stylebiopsy system forhistological biopsy onsoft tissue. | Disposableprogrammableautomatic spring-loaded guillotine stylebiopsy system forhistological biopsy onsoft tissue. | Same |
| Intended Use/Indications for Use | Automatic biopsyneedles are intended inobtaining biopsysamples from softtissues such as liver,kidney, prostate,breast, lymph nodesand various soft tissuetumors. It is notintended for use inbone. | Medax MEDONE ULTRAintended for use inobtaining core biopsysamples from softtissue such as kidney,liver, prostrate, spleen,lymph nodes, andvarious soft tissuemasses. Not intendedfor use in bone. | Same |
| Target Population | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Same |
| Mechanics ofOperation | Single hand automaticactivation | Single hand automaticactivation | Same |
| Gauge | 12G-20G | 14G-20G | DifferentThe subjectdevice hassmaller gaugethan predicatedevice |
| Needle Length | 90mm-200mm | 60 mm to 200 mm | DifferentThe range ofneedle length in |
| subject device iswithin that ofpredicate device. | |||
| Patient/TissueContact Material | Inner needle and outerneedle are made out of304 stainless steel(X5CrNi18-10).Only Stainless steel is indirect surgical contactwith all soft tissues ofthe patient. | Cannula and mandrelare made out of AISI304 stainless steel.Only Stainless steel is indirect surgical contactwith all soft tissues ofthe patient. | Same |
| Performance | Complied with ISO 9626 | Complied with ISO 9626 | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Biocompatibleaccording to ISO 10993applicable parts | Biocompatibleaccording to ISO 10993applicable parts | Same |
Table 1. Comparison of the Promisemed Automatic Biopsy Needle to the predicate device.
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Table 2: Comparison of the Promisemed Semi-automatic Biopsy Needle to the predicate device.
| Subject Device | Predicate Device(K181803) | ||
|---|---|---|---|
| Trade Name | Promisemed Semi-automatic BiopsyNeedle | MEDEXTRA | Comments |
| Manufacturer | Promisemed HangzhouMeditech 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 BiopsyInstrument | Gastroenterology-Urology BiopsyInstrument | Same |
| Device Description | Disposable semi-automatic springloaded guillotine stylebiopsy system withadjustable penetrationdepth for histologicalbiopsy on soft tissue. | Disposable semi-automatic springloaded guillotine stylebiopsy system withadjustable penetrationdepth for histologicalbiopsy on soft tissue. | Same |
| IntendedUse/Indications for Use | Semi-automatic biopsyneedles are intended inobtaining biopsysamples from soft | The device is intendedfor use in obtainingbiopsies from softtissues such as liver | Same |
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| tissues such as liver,kidney, prostate,breast, lymph nodesand various soft tissuetumors. It is notintended for use inbone. | kidney, prostate,breast, spleen, lymphnodes and various softtissue masses. It is notintended for use inbone biopsy. | ||
|---|---|---|---|
| Target Population | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Same |
| Mechanics ofOperation | Single hand automaticactivation | Single hand automaticactivation | Same |
| Gauge | 14G-20G | 14G-20G | Same |
| Needle Length | 90mm-220mm | 80 mm to 300 mm | DifferentThe range ofneedle length insubject device iswithin that ofpredicate device. |
| Patient/TissueContact Material | Inner needle and outerneedle are made out of304 stainless steel(X5CrNi18-10).Only Stainless steel is indirect surgical contactwith all soft tissues ofthe patient. | Cannula and mandrelare made out of AISI304 stainless steel.Only Stainless steel isin direct surgicalcontact with all softtissues of the patient. | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Biocompatibleaccording to ISO 10993applicable parts | Biocompatibleaccording to ISO 10993applicable 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 BiopsyNeedle | Perineologic AccessNeedle | Comments |
| Manufacturer | Promisemed HangzhouMeditech Co., Ltd | Corbin ClinicalResources, LLC | |
| Device Class | Class II | Class II | Same |
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| Product Code | FCG | FCG | Same |
|---|---|---|---|
| Regulation number | 876.1075 | 876.1075 | Same |
| Regulation Name | Gastroenterology-Urology BiopsyInstrument | Gastroenterology-Urology BiopsyInstrument | Same |
| Intended Use/Indications for Use | Co-axial biopsy deviceis mainly used to guidethe insertion of biopsyneedle into the softtissue under imagingcontrol (ultrasound, X-ray, CT, etc.). It is notintended for use inbone. | The Perineologic AccessNeedle is intended foruse as a guiding needlein obtaining core biopsysamples from softtissue and tumors ofsuch organs as liver,kidney, spleen, lymphnodes, prostate, lungand various soft tissuelesions. | Same |
| Target Population | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Same |
| Gauge | 11G-19G | 14G-20G | Different |
| The subjectdevice hassmaller gaugethan predicatedevice. | |||
| Needle Length | 60mm-190mm | 70 mm to 200 mm | Different |
| The subjectdevice hasshorter needlelength thanpredicate device. | |||
| Device Type | Trocar tip stylet with/without blunt tip stylet | Trocar tip stylet | Different |
| Subject devicehas blunt tipstylet as anoption tominimize the riskof unintentionaldamage to targettissue. | |||
| VisualizationTechnique | Conventional imagingguidance equipmentexcluding MRI | Conventional imagingguidance equipmentexcluding MRI | Same |
| Needle Material | Stainless steel | Stainless steel | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | |||
| Biocompatibleaccording to ISO 10993applicable parts | Biocompatibleaccording to ISO 10993applicable parts | Same |
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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.
§ 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.