(24 days)
The Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is intended for obtaining a percutaneous soft tissue biopsy.
The subject device is a sterile disposable product featuring a stationary stylet that punctures, a spring activated cannula that cuts and a SNARECOIL that captures tissue. The device functions by pulling back the pull ring until the trigger cocks and pressing the trigger until the device fires. The biopsy is captured by the snare located inside the outer needle cannula.
The provided text indicates that the device, the Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle, did not undergo a clinical study. Instead, its acceptance was based on non-clinical performance verification testing and a demonstration of substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Acceptability (Non-Clinical) | Performance verification testing demonstrated that the SNARECOIL Soft Tissue Biopsy (GSS) Needle is functionally acceptable. |
| Substantial Equivalence to Predicate Devices | Based on similarities in materials, design, operating principles, biocompatibility, and sterilization method, the GSS Biopsy Needle has been shown to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document explicitly states "Clinical Data: Not Applicable." The performance verification was non-clinical.
- Data Provenance: Not applicable, as no clinical data was used. The non-clinical data would have been generated internally by Ranfac Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No experts were mentioned for establishing ground truth as there was no clinical test set. The functional acceptability for the non-clinical testing would have been evaluated against internal company specifications and standards.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set or human interpretation involved to require an adjudication method.
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
- No. The document explicitly states "Clinical Data: Not Applicable," and there is no mention of AI assistance or human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical biopsy needle, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance verification, the "ground truth" would have been established by the device's functional specifications and engineering requirements (e.g., successful tissue capture, firing mechanism functionality, material integrity). This isn't external pathology or outcomes data but internal test results against predefined criteria.
8. The sample size for the training set
- Not applicable. The device is a physical medical instrument, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set for an AI or algorithm.
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MAY 2 3 2003
K031 344 510(k) Summary (Page 1 of 2)
| Submitter's Name and Address: | Ranfac Corporation30 Doherty AvenueAvon, MA 02322-0635 |
|---|---|
| Manufacturer's Contact Person: | Barry ZimbleExecutive Vice PresidentTel: (508) 588-4400Fax: (508) 584-8588 |
| Date Summary Prepared: | April 21, 2003 |
| Device Trade Name: | Goldenberg SNARECOIL™ Soft Tissue Biopsy(GSS) Needle |
| Common name:Classification Name: | Biopsy NeedleBiopsy Instrument (21 CFR 876.1075) ProductCodes: KNW, FCG |
| Predicate Device(s): | Ranfac Single Action Biopsy NeedleRanfac Goldenberg Bone Marrow Biopsy NeedleEthicon Endo-Surgery Inc. Mammotome Hand Hel11 Gauge Biopsy Probe |
| Device Description: | The subject device is a sterile disposable productfeaturing a stationary stylet that punctures, a spring activated cannula that cuts and a SNARECOIL thatcaptures tissue. The device functions by pullingback the pull ring until the trigger cocks andpressing the trigger until the device fires. Thebiopsy is captured by the snare located inside theouter needle cannula. |
| Intended Use: | The Goldenberg SNARECOIL™ Soft TissueBiopsy (GSS) Needle is intended for obtaining apercutaneous soft tissue biopsy. |
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510(k) Summary K031344 (page 2 of 2)
:
| Technological Characteristics: | The proposed device has similar technologicalcharacteristics and is similar in design andconfiguration compared with the predicate devices. |
|---|---|
| Non-Clinical Data: | Performance verification testing demonstrated thatthe SNARECOIL Soft Tissue Biopsy (GSS) Needleis functionally acceptable. |
| Clinical Data: | Not Applicable |
| Conclusion: | Based on similarities in materials, design, operatingprinciples, biocompatibility and sterilization methodbetween the GSS Biopsy Needle subject of thispremarket notification and the predicate devices, theGSS Biopsy Needle has been shown to besubstantially equivalent to predicate devices underthe Federal Food, Drug and Cosmetic Act. |
:
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Public Health Service
.
MAY 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Barry Zimble Executive Vice President Ranfac Corporation 30 Doherty Avenue Avon, Massachusetts 02322-0635
Re: K031344
Trade/Device Name: Goldenberg Snarecoil™ Soft Tissue Biopsy (GSS) Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: April 23, 2003 Received: May 1, 2003
Dear Mr. Zimble:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Barry Zimble
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
ﺔ ﻣﺪﺗﻤ ﺗﻤ
For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K031344 510(k) Number (if known):
Device Name: Ranfac Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle
The GSS Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031344
Prescription Use
OR
Over-the -Counter Use (Per 21 CFR 801.109)
§ 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.