Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition.

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.

Device Description

Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices. Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps. CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive. CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.

AI/ML Overview

This document is a 510(k) summary for Reprocessed Used Disposable Biopsy Forceps by Clear Medical, Inc. It mainly focuses on the substantial equivalence of the reprocessed devices to new predicate devices. It does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria in the way a clinical study would for efficacy/performance claims.

Here's an analysis based on the provided text, focusing on what can be extracted or inferred about acceptance criteria directly related to the reprocessing and substantial equivalence, rather than a clinical performance study.

1. A table of acceptance criteria and the reported device performance

Based on the nature of this 510(k) submission, "performance" here refers to the ability of the reprocessed device to meet the functional and safety characteristics of the original device after reprocessing, demonstrating substantial equivalence. The document doesn't provide a table of precise quantitative acceptance criteria with reported numerical performance values from a study. However, it implicitly states the requirement for the reprocessed device to perform equivalently to the new predicate device.

The acceptance criteria for "reprocessed" devices, as stated by Clear Medical, are defined by the FDA's Compliance Policy Guide #7124.16 related to "reusable - by Clear Medical" devices:

Ability to withstand necessary cleaning and sterilization processes.
Physical characteristics or quality of the device will not be adversely affected.
The device remains safe and effective for its intended use.

The document states that Clear Medical believes these conditions are met, and the FDA's 510(k) clearance implies that the provided data (though not detailed here) was sufficient to demonstrate this belief as valid for substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size, data provenance, or study design (retrospective/prospective) for any specific testing related to establishing substantial equivalence. The submission is for "Reprocessed Used Disposable Biopsy Forceps," indicating that the "test set" would be reprocessed devices. The original disposable biopsy forceps were manufactured by Microvasive.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This 510(k) summary does not mention the use of experts to establish a "ground truth" in the context of a clinical performance study. The primary focus is on the substantial equivalence of the reprocessed device to the predicate device, which would typically involve engineering and sterilization validation rather than expert clinical assessment of patient outcomes for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as a clinical test set requiring adjudication by experts is not described in this document.

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

Not applicable. This document pertains to the reprocessing of medical devices (biopsy forceps), not an AI-assisted diagnostic tool or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document pertains to the reprocessing of medical devices (biopsy forceps), not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" for substantial equivalence would likely revolve around:

Functional equivalence: Demonstrating that the reprocessed device performs the biopsy function (e.g., tissue sample acquisition) comparably to new devices. This might involve mechanical testing, tissue grip tests, cutting performance.
Sterility: Proving that the device is sterile after reprocessing.
Material integrity: Ensuring the device materials do not degrade and no toxic residues remain after reprocessing. This would involve chemical analysis, material compatibility testing, and biocompatibility.
Biocompatibility: Demonstrating that the reprocessed materials are still biocompatible.

The document does not provide details on which specific "ground truth" methods were employed, but these are typical for reprocessing validations.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an algorithm based on machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an algorithm.

Summary

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Image /page/0/Picture/0 description: This image shows a document with the date November 20, 2003, at the top left. Below the date is the text "CLEAR MEDICAL, INC." in large, bold letters. At the top right of the image is the number K033593, and below that is the text "Page 1 of 1".

776-1360 Place NE Bellevue, WA 98005-2328 Tel: (425) 401.1414 Fax: (425) 401.1515

510(k) SUMMARY

Clear Medical, Incorporated Reference: Section 510(k) Notification Reprocessed Single Use, Electric and Mechanical Biopsy Forceps

Classification name:	Instrument, Biopsy, Mechanical, Gastrointestinal
Common/Usual Name:	Gastrointestinal Biopsy Forceps
Proprietary Name:	Reprocessed Biopsy Forceps
Establishment Reg. No.:	3017110
Classification:	The FDA has classified gastrointestinal biopsy forceps as a
	Class II device in 21 CFR 876.1075.

Clear Medical intends to market Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical 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). Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices.

Clear Medical believes that Used Disposable Biopsy Forceps can be considered "reusable - by Clear Medical" 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.

Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition.

Clear Medical 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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and two curved lines representing its tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 6 2007

Mr. Mike Kovacs Clear Medical, Inc. 1776-136th Place NE BELLVUE WA 98005-2328

Re: K033593

Trade/Device Name: SEE ENCLOSURE 1 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLU Dated: November 7, 2003 Received: November 13, 2003

Dear Mr. Kovacs:

This letter corrects our substantially equivalent letter of November 20, 2003.

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 (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 vour 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 (OS) 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 continue 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 (240) 276-0115. 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 from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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

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K033593
Page 1 of 1

510)k) Number:

K033593

Device Name:

Reprocessed Used Disposable Biopsy Forceps

CMI 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.

CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.

(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)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .

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ENCLOSURE 1 K033593

Adven Medical, Inc Reprocessed Mechanical and Electric Single Use 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

K033593 Clear Medical, Inc Reprocessed Mechanical and Electric Single Use Biopsy Forceps

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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)	Color Code
1273	2.2	240	2.8	Orange
1274 with needle	2.2	240	2.8	Orange

11:11:1

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

Clear Medical, Inc Reprocessed Mechanical and Electric . Single Use . Biopsy Forceps K033593

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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
1597with needle	2.2	160	2.8	Yellow
1598	2.2	240	2.8	Orange
1599 with needle	2.2	240	2.8	Orange

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Radial Jaw 3 Large Capacity Single-Use Biopsy Forceps

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

: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :

Carlos Concession

: :

1 .

:

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

: 1

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K033593 Clear Medical, Inc Reprocessed Mechanical and Electric Single Use Biopsy Forceps

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400		100	1	Rine
(	1			Blue
1268with needle	14 4 6		ﺎ	Rue
1760with needleA A B - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A		CAA		Rue

1530 (Box 5)	2.2	100	2.8	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

. ' -

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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

100 - 100

: 上一篇:

and the comments of the comments of

and the consideration of the control of

and the comments of the comments of

. .

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: : 上

K033593 Clear Medical, Inc Reprocessed Mechanical and Electric Single Use Biopsy Forceps

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).