Who is the manufacturer of REPROCESSED COLD BIOPSY FORCEPS?

Sterilmed, Inc. filed the 510(k) submission for REPROCESSED COLD BIOPSY FORCEPS (K042648).

What is the FDA product code for REPROCESSED COLD BIOPSY FORCEPS?

NON. It is classified under 21 CFR 876.1075 as a Class 1 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for REPROCESSED COLD BIOPSY FORCEPS?

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

What are the predicate devices for REPROCESSED COLD BIOPSY FORCEPS?

Precisor EXL Cold biopsy Forceps (Bard); Radial Jaw 3 Cold biopsy forceps (Microvasive).

Who can help prepare an FDA 510(k) submission like REPROCESSED COLD BIOPSY FORCEPS?

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.

REPROCESSED COLD BIOPSY FORCEPS

K042648 · Sterilmed, Inc. · NON · Jul 20, 2005 · Gastroenterology, Urology

Device Facts

Record ID	K042648
Device Name	REPROCESSED COLD BIOPSY FORCEPS
Applicant	Sterilmed, Inc.
Product Code	NON · Gastroenterology, Urology
Decision Date	Jul 20, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 1

Intended Use

The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. These forceps are advanced to the site for sampling via the operating channel of an endoscope.

Device Story

Reprocessed cold biopsy forceps; mechanical instrument for tissue sampling. Device comprises proximal handle connected via coil, spring, or rod mechanism to distal biopsy jaws. Lengths 100-240cm; diameters 1.8-3.3mm. Jaws feature various configurations including serrated edges, fenestrations, needles, or biting teeth. Used in clinical settings during endoscopic procedures; operated by physicians. Device advanced through endoscope operating channel to target site; jaws manipulated to excise tissue for histologic examination. Reprocessing restores device functionality; cleaning and sterilization validated to ensure safety. Benefits include providing tissue samples for diagnosis while utilizing reprocessed, cost-effective instrumentation.

Clinical Evidence

Bench testing only. Representative samples underwent functional testing. Process validation performed for cleaning, sterilization, and packaging. Manufacturing process includes visual and functional testing of all units.

Technological Characteristics

Mechanical biopsy instrument. Components: proximal handle, coil/spring/rod mechanism, distal biopsy jaws. Dimensions: 100-240cm length, 1.8-3.3mm diameter. Jaw features: serrated, fenestrated, needle, or biting tooth. No energy source. Manual operation. Sterilization via validated reprocessing procedures.

Indications for Use

Indicated for use during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination in patients requiring biopsy.

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

Precisor EXL Cold biopsy Forceps (Bard)
Radial Jaw 3 Cold biopsy forceps (Microvasive)

Related Devices

K022751 — REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS · Medical Device Services · Nov 4, 2002
K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS · Clearmedical, Inc. · Nov 20, 2003
K042659 — MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS · Medisiss · Feb 14, 2005
K042594 — VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS · Vanguard Medical Concepts, Inc. · Jan 25, 2005
K050136 — REPROCESSED HOT BIOPSY FORCEPS · Sterilmed, Inc. · Jul 20, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ K042648 Page 1 of 2 # SECTION 2. SUMMARY AND CERTIFICATION ### 2.A. 510(k) Summary | Submitter: | SterilMed, Inc. | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dr. Bruce Lester SterilMed, Inc. 11400 73rd Avenue North Minneapolis, MN 55369 Ph: 763-488-3400 Fax: 763-488-3350 | | Date Prepared: | September 26, 2004 | | Trade Name: | Reprocessed Cold Biopsy Forceps | | Classification Name: and Number: | Gastroenterology-Urology Biopsy Instruments Class I, 21 CFR 876.1075 | | Product Code: | NON | | Predicate Device(s): | The reprocessed cold biopsy forceps are substantially equivalent to the Precisor EXL Cold biopsy Forceps manufactured by Bard and the Radial Jaw 3 Cold biopsy forceps manufactured by Microvasive. Both of the predicate devices are Class 1 devices. | | Device Description: | The device consists of a proximal handle which is connected, via a coil, spring or rod mechanism, to the biopsy jaws at the distal tip. The biopsy forceps range from 100 to 240cm in length and 1.8-3.3mm in diameter. The jaws range from 1.8 to 3.3mm in diameter. The jaws of the forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth. | {1}------------------------------------------------ K042648 Page 2 of 2 | Intended Use: | The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. These forceps are advanced to the site for sampling via the operating channel of an endoscope. | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Functional and Safety Testing: | Representative samples of reprocessed cold biopsy forceps underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. | | Conclusion: | The cold biopsy forceps reprocessed by SterilMed are substantially equivalent to their counterparts from the original manufacturers and to the Precisor EXL Cold Biopsy Forceps manufactured by Bard and the Radial Jaw 3 Cold biopsy forceps manufactured by Microvasive. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction. | {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows a circular logo with a stylized eagle in the center. The eagle is depicted with three distinct wing segments, giving it a sense of motion or flight. Encircling the eagle is text, which appears to be part of the logo's official name or designation. The logo has a simple, black-and-white design, making it easily recognizable. #### JUL 2 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050 Bruce R. Lester, Ph.D. Vice President of R&D SterilMed, Inc. 11400 73rd Avenue, North JUL 20 2005 MINNEAPOLIS MN 55369 \$ Re: K042648 K042046 Trade/Device Name: SterilMed Reprocessed Cold Biopsy Forceps (see enclosure) Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: I Product Code: NON Dated: April 28, 2005 Received: April 29, 2005 Dear Dr. Lester: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your boarded by of substantially equivalent (for the indications for use stated in above and have decemined the ad predicate devices marketed in interstate commerce prior to the enclosale) to tegarry manced procession in the Medical Devices that have been May 20, 1970, the Chacanent acts of the Federal Food, Drug, and Cosmetic Act (Act) that recrassified in accordation that are frences approval application (PMA). You may, therefore, market the do not required or a premation sperior special of the Act. The general controls provisions of the Act device, subject to the general volusions provinces, 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 (Premarket If your device is classified (600 able additional controls. Existing major regulations affecting your Approval), it thay of subject to such ademic Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be found in ther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FICASE be advised that I DA 3 issualled of levice complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all the Federal Slaudes and regulations administer of of the may and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 8017, good manalactions Fregulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antire of your device of your device to a legally premarket notification. The FDA finding of substantial equir device of y premarket notification. The FDA Inding of substantial of 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), pleased If you desire specific advice for your device on our laboring regarmed ( contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premazed notification" (21 CFR Also, please note the regulation entitled, "Misoriation on your responsibilities under the Act from the 807.97). You may obtain other gelleral information on your repears. Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) Division of Binan Mass 6597 or at its Internet address 056-2017-01-01-11-01-11-2014/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | Original Manufacturer (BARD) | Cup Type | Jaw Size (mm) | Length (cm) | |---------------------------------------------------------------------|---------------------------------------|------------------|-------------| | Manufacturer Number | | | | | 000381 | Alligator | 2.3 | 160 | | 000382 | Alligator w/ Needle | 2.3 | 160 | | 000383 | Oval | 2.3 | 160 | | 000384 | Oval w/ Needle | 2.3 | 160 | | 000385 | Alligator w/ Needle | 2.3 | 230 | | 000386 | Alligator w/ Needle | 2.3 | 230 | | 000388 | Oval w/ Needle | 2.3 | 230 | | 000389 | Oval | 2.3 | 230 | | 00820C | Oval | 3.1 | 230 | | 00821C | Oval w/ Needle | 3.1 | 230 | | 00822C | Alligator | 3.1 | 230 | | 00823C | Alligator w/ Needle | 3.1 | 230 | | 100512 | Oval | 1.8 | 160 | | 100513 | Alligator | 1.8 | 160 | | 000837 | Oval | 2.3 | 160 | | 000838 | Oval w/ Needle | 2.3 | 160 | | 000840 | Alligator | 2.3 | 160 | | 000841 | Alligator w/ Needle | 2.3 | 160 | | 000816 | Oval | 2.3 | 230 | | 000817 | Oval w/ Needle | 2.3 | 230 | | 000818 | Alligator | 2.3 | 230 | | 000819 | Alligator w/ Needle | 2.3 | 230 | | 000820 | Oval | 3.1 | 230 | | 000821 | Oval w/ Needle | 3.1 | 230 | | 000822 | Alligator | 3.1 | 230 | | 000823 | Alligator w/ Needle | 3.1 | 230 | | 100516 | Oval | 1.8 | 160 | | 100517 | Alligator | 1.8 | 160 | | Original Manufacturer (Microvasive) Manufacturer Number | Cup Type | Jaw Size (mm) | Length (cm) | | 1530 | Alligator | 2.2 | 100 | | 1531 | Alligator w/ Needle | 2.2 | 100 | | 1534 | Alligator | 2.2 | 160 | | 1535 | Alligator w/ Needle | 2.2 | 160 | | 1536 | Alligator | 2.2 | 240 | | 1537 | Alligator w/ Needle | 2.2 | 240 | | 1596 | Large Capacity Alligator | 2.2 | 160 | | 1597 | Large Capacity Alligator w/ Needle | 2.2 | 160 | | 1598 | Large Capacity Alligator | 2.2 | 240 | | 1599 | Large Capacity Alligator w/ Needle | 2.2 | 240 | | 1586 | Max Capacity Alligator | 3.3 | 160 | | 1587 | Max Capacity Alligator w/ Needle | 3.3 | 160 | | 1588 | Max Capacity Alligator | 3.3 | 240 | | 1589 | Max Capacity Alligator w/ Needle | 3.3 | 240 | | 1578 | Alligator | 1.8 | 160 | | 1579 | Alligator w/ Needle | 1.8 | 160 | | 1265 | Alligator w/Needle | 2.2 | 240 | | 1260 | Alligator | 2.2 | 160 | | 1263 | Alligator w/ Needle | 2.2 | 160 | | 1271 | Alligator | 2.2 | 240 | | 1584 | Max Capacity Alligator | 3.3 | 240 | | 1585 | Max Capacity Alligator w/ Needle | 3.3 | 240 | | 1274 | Large Capacity Alligator w/ Needle | 2.2 | 240 | | 1281 | Alligator | 1.8 | 160 | | 1286 | Alligator w/ Needle | 1.8 | 160 | | 1010 | Multiple Sample Alligator | 2.4 | 160 | | 1012 | Multiple Sample Alligator | 2.4 | 240 | | 1268 | Alligator w/ Needle | 2.2 | 100 | | Original Manufacturer (Wilson-Cook) | Cup Type | Jaw Size (mm) | Length (cm) | | Manufacturer Number | | | | | SDF -2.5 -160 | Fenestrated | 2.5 | 160 | | SDF -2.5 -160-S | Fenestrated w/ Needle | 2.5 | 160 | | SDF -2.5 - 230 | Fenestrated | 2.5 | 230 | | SDF -2.5 - 230-S | Fenestrated w/ Needle | 2.5 | 230 | #### ENCLOSURE Table 1 - BARD Cold Biopsy Forceps to be Reprocessed 体育 3 : : {5}------------------------------------------------ ## Table 2 - Microvasive Cold Biopsy Forceps to be Reprocessed : : 上一篇: {6}------------------------------------------------ #### Table 3 - Wilson-Cook Cold Biopsy Forceps to be Reprocessed : : ﺳﻪ ۱۰ ۰۰۰ -۰۰- . . . : : . 1988 - 1 : {7}------------------------------------------------ #### Indications for Use Page Device Name: Reprocessed Cold Biopsy Forceps · ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· · Indications for Use: The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. These forceps are advanced to the site for sampling via the operating channel of an endoscope. Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Brogdon (Division Sign-Off) Division of Reproduct ive, Abdominal. and Radiological Devices 510(k) Number K042644 Prescription Use (Per 21 CFR 801.109)