Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

MDS reprocessed biopsy forceps are disposable unless reprocessed again by MDS.

Device Description

MDS intends to market Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by MDS to MDS protocol Number 40003.

"Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). MDS is a "third party reprocessor" and reprocesses used, single-use medical devices.

MDS believes that Used Disposable Biopsy Forceps can be considered "reusable - by MDS" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.

Biopsy forceps are long instruments with a small jaw type mechanism on one end and a handle mechanism on the other. Forceps are designed to collect tissue samples.

AI/ML Overview

The provided text is a 510(k) summary and FDA clearance letter for a reprocessed medical device (biopsy forceps). It does not contain information about studies related to AI/algorithm performance. Therefore, I cannot generate an answer that includes details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for AI-based devices.

The document discusses the substantial equivalence of the reprocessed physical device to legally marketed predicate devices, focusing on the ability of the physical device to withstand reprocessing and remain safe and effective for its intended use. There is no mention of any AI or algorithmic component in the reprocessed biopsy forceps.

Summary

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Medical Device Services, I

144 West Brigham Road, Bldg. E. St. George, UT 84790

K022751/
Page 1 of 1

Tel: (435) 652-307. Fax: (435) 652-3087

510(k) SUMMARY

4 2002 NOV

Reference: Medical Device Services, Incorporated Section 510(k) Notification MDS Reprocessed Biopsy Forceps

Classification name:	Instrument, Biopsy, Mechanical, Gastrointestinal
Common/Usual Name:	Gastrointestinal Biopsy Forceps
Proprietary Name:	MDS Reprocessed Biopsy Forcep
Establishment Reg. No.:	1724309
Classification:	The FDA has classified gastrointestinal biopsy forceps as aClass II device in 21 CFR 876.1075.

MDS intends to market Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by MDS to MDS protocol Number 40003.

Biopsy forceps are long instruments with a small jaw type mechanism on one end and a handle mechanism on the other. Forceps are designed to collect tissue samples.

Medical Device Services, Reprocessed Used Disposable Biopsy Forceps are substantially equivalent to disposable biopsy forceps currently marketed new by Microvasive under 510(k) 932266.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

NOV 4 2002	Food and Drug Administration9200 Corporate BoulevardRockville MD 20850
Medical Device Servicesc/o Mr. Mark W. AldanaPresidentAdven Medical, Inc.1001 Slaton Hwy.LUBBOCK TX 79404	Re: K022751
	Trade/Device Name: Reprocessed Used DisposableBiopsy Forceps (SEE ENCLOSURE 1)
	Regulation Number: 21 CFR §876.4300
	Regulation Name: Endoscopic electrosurgical unitand accessories
	Regulatory Class: II
	Product Code: 78 KGE
	Regulation Number: 21 CFR §876.1075
	Regulation Name: Gastroenterology-urology biopsy instrument
	Regulatory Class: I
	Product Code: 78 FCL
	Dated: August 9, 2002
	Received: August 19, 2002

Dear Mr. Aldana:

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 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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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	: (301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	: (301) 594-4654
Other	(301) 594-4692

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" (21 CFR Part 807.97). 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ENCLOSURE 1 K022751

CLASS I: FCL 21CFR §876.1075

Medical Device Services Reprocessed Used Disposable Mechanical and Electric Biopsy Forceps

Manufacturer: MICROVASIVE

Radial Jaw* 3 Max Capacity Single-Use Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1586	3.3	160	3.8	Yellow
1587 with needle	3.3	160	3.8	Yellow
1588	3.3	240	3.3	Orange
1589 with needle	3.3	240	3.8	Orange

Radial Jaw* II Single-Use Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1562	2.2	160	2.8	Yellow
1563 with needle	2.2	160	2.8	Yellow
1564	2.2	240	2.8	Orange
1565 with needle	2.2	240	2.8	Orange

Radial Jaw* LC II Large Capacity Single-Use Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1591	2.2	160	2.8	Yellow
1592 with needle	2.2	160	2.8	Yellow
1593	2.2	240	2.8	Orange
1594 with needle	2.2	240	2.8	Orange

Radial Jaw Single-Use Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1260	2.2	160	2.8	Yellow
1263 with needle	2.2	160	2.8	Yellow
1271	2.2	240	2.8	Orange
1265 with needle	2.2	240	2.8	Orange

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Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1260	2.2	160	2.8	Yellow
1263 with needle	2.2	160	2.8	Yellow
1271	2.2	240	2.8	Orange
1265 with needle	2.2	240	2.8	Orange
1582	3.3	160	3.8	Yellow
1583 with needle	3.3	160	3.8	Yellow
I 584	3.3	240	3.8	Orange
1585 with needle	3.3	240	3.8	Orange

Radial Jaw MC 3.3 Single-Use Max Capacity Biopsy Forceps

Radial Jaw LC Large Capacity Single-Use Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1273	2.2	240	2.8	Orange
1274 with needle	2.2	240	2.8	Orange

Radial Jaw GP Gastro-pediatric Single-Use Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1281	1.8	160	2.0	Yellow
1286 with needle	1.8	160	2.0	Yellow

Multibite''' Multiple Sample Single-Use Biopsy Forceps

Manufacturer Numbers	Length(cm)	Working Channel(mm)
1010	160	2.8
1012	240	2.8

Radial Jaw 3"' Single-Use Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1534 (Box 5)	2.2	160	2.8	Yellow
1535 with needle (Box 5)	2.2	160	2.8	Yellow
1536 (Box 5)	2.2	240	2.8	Orange
1537 with needle (Box 5)	2.2	240	2.8	Orange

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Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)	Working Channel(mm)	ColorCode
1281	1.8	160	2.0	Yellow
1286 with needle	1.8	160	2.0	Yellow
1596	2.2	160	2.8	Yellow
1597 with needle	2.2	160	2.8	Yellow
1598	2.2	240	2.8	Orange
1599 with needle	2.2	240	2.8	Orange

. . . .

Radial Jaw 3 Large Capacity Single-Use Biopsy Forceps

CLASS II; KGE; 21CFR §876.4300

Radial Jaw''' 3 Single-Use Hot Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)
1550 (Box 5) (Olympus® Connector)	2.2	240
1551 (Box 5) (Microvasive® Connector)	2.2	2.40

. · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Radial Jaw Hot Biopsy Forceps

Manufacturer Numbers	Jaw O.D.(mm)	Length(cm)
1274 (Box 5) (Microvasive® Connector)	2.2	240
1277 (Box 5) (Olympus® Connector)	2.2	2.40

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1266	1.8	100	2.0	Blue
1267	2.2	100	2.8	Blue
1268 with needle	2.2	100	2.8	Blue
1269 with needle	1.8	100	2.0	Blue

1531	with needle (Box 5)	2.2	100	2.8	Blue
1266		1.8	100	2.0	Blue
1267		2.2	100	2.8	Blue
1268	with needle	2.2	100	2.8	Blue
1269	with needle	1.8	100	2.0	Blue

100

2.2

2.8

Blue

XX 1260-20 Radial Jaw 20-pack 2.2 160 2.8 Yellow

1530 (Box 5)

XX 1263-20 Radial Jaw 20-pack with needle 2.2 160 2.8 Yellow

XX 1265-20 Radial Jaw 20-pack with needle 2.2 240 2.8 Orange

XX1267-20 Radial Jaw 20-pack 2.2 240 2.8 Orange

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Page 1 of

510(k) Number:

K022751

Device Name:

Reprocessed Used Disposable Biopsy Forceps

Medical Device Services (MDS) intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive.

Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract

Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

MDS reprocessed biopsy forceps are disposable unless reprocessed again by MDS.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

David A. Szymon

on Sign-Off of Reproductive. Abdominal onical Davies

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).