(24 days)
Not Found
Not Found
No
The description focuses on the mechanical function of the device (puncture, cut, capture) and does not mention any computational or data-driven processes indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
The device is a biopsy needle, used for obtaining tissue samples for diagnostic purposes, not for treating a disease or condition.
Yes
The device's intended use is "for obtaining a percutaneous soft tissue biopsy," which is a procedure performed to diagnose diseases or conditions by examining tissue samples.
No
The device description clearly describes a physical, sterile, disposable product with mechanical components (stylet, cannula, SNARECOIL, pull ring, trigger) used for obtaining a tissue biopsy. There is no mention of software as the primary or sole component.
Based on the provided information, the Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for obtaining a percutaneous soft tissue biopsy." This describes a procedure to collect a tissue sample from a living patient.
- Device Description: The description details a mechanical device used for physically obtaining a tissue sample.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside of the body (in vitro) to provide information about a patient's health. They typically involve reagents, assays, or analytical processes performed on samples like blood, urine, or tissue after they have been collected. This device is used during the collection process.
The Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is a surgical or procedural device used for tissue collection, not for performing diagnostic tests on the collected tissue.
N/A
Intended Use / Indications for Use
The Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is intended for obtaining a percutaneous soft tissue biopsy.
The GSS Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Performance verification testing demonstrated that the SNARECOIL Soft Tissue Biopsy (GSS) Needle is functionally acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ranfac Single Action Biopsy Needle, Ranfac Goldenberg Bone Marrow Biopsy Needle, Ethicon Endo-Surgery Inc. Mammotome Hand Hel 11 Gauge Biopsy Probe
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY 2 3 2003
K031 344 510(k) Summary (Page 1 of 2)
| Submitter's Name and Address: | Ranfac Corporation
30 Doherty Avenue
Avon, MA 02322-0635 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer's Contact Person: | Barry Zimble
Executive Vice President
Tel: (508) 588-4400
Fax: (508) 584-8588 |
| Date Summary Prepared: | April 21, 2003 |
| Device Trade Name: | Goldenberg SNARECOIL™ Soft Tissue Biopsy
(GSS) Needle |
| Common name:
Classification Name: | Biopsy Needle
Biopsy Instrument (21 CFR 876.1075) Product
Codes: KNW, FCG |
| Predicate Device(s): | Ranfac Single Action Biopsy Needle
Ranfac Goldenberg Bone Marrow Biopsy Needle
Ethicon Endo-Surgery Inc. Mammotome Hand Hel
11 Gauge Biopsy Probe |
| Device Description: | 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. |
| Intended Use: | The Goldenberg SNARECOIL™ Soft Tissue
Biopsy (GSS) Needle is intended for obtaining a
percutaneous soft tissue biopsy. |
1
510(k) Summary K031344 (page 2 of 2)
:
| Technological Characteristics: | The proposed device has similar technological
characteristics and is similar in design and
configuration compared with the predicate devices. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Data: | Performance verification testing demonstrated that
the SNARECOIL Soft Tissue Biopsy (GSS) Needle
is functionally acceptable. |
| Clinical Data: | Not Applicable |
| Conclusion: | Based on similarities in materials, design, operating
principles, biocompatibility and sterilization method
between the GSS Biopsy Needle subject of this
premarket notification and the predicate devices, the
GSS Biopsy Needle has been shown to be
substantially equivalent to predicate devices under
the Federal Food, Drug and Cosmetic Act. |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
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.
3
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
4
ﻳﻢ ﻻﻋﺘﻤﺎﻋﺎ ﻟﻠﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
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)