Predicate Devices

932266

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes the reprocessing of single-use biopsy forceps and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The device is used for diagnostic purposes (tissue sample acquisition, polyp removal for examination) rather than directly treating a disease or condition. While removing polyps can be considered therapeutic in some contexts, the primary stated use is "tissue sample acquisition" and "remove polyps and/or tissue specimens throughout the alimentary tract," which often precedes diagnostic analysis. It functions more as a tool for a procedure rather than delivering a therapy itself.

Diagnostic

Yes
The device is used for "endoscopic tissue sample acquisition" and to "remove polyps and/or tissue specimens," which are then typically sent for pathological examination to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a reprocessed physical medical device (biopsy forceps) and does not mention any software component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to acquire tissue samples and remove polyps during GI procedures. This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
Device Description: The device is a biopsy forceps, which is a tool used to physically obtain tissue. It does not perform any analysis or testing on the tissue itself.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like reagents, analyzers, or diagnostic assays).

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device is used to collect the specimen, not to analyze it.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

NLU

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

alimentary tract

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)

Not Found

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.

932266

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

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).

Summary

0

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.

1

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.

2

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

3

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)

OR

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 .

4

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) | Color
Code |
|----------------------|------------------|----------------|-------------------------|---------------|
| 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) | Color
Code |
|----------------------|------------------|----------------|-------------------------|---------------|
| 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) | Color
Code |
|----------------------|------------------|----------------|-------------------------|---------------|
| 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) | Color
Code |
|----------------------|------------------|----------------|-------------------------|---------------|
| 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

5

| Manufacturer Numbers | Jaw O.D.
(mm) | Length
(cm) | Working Channel
(mm) | Color
Code |
|----------------------|------------------|----------------|-------------------------|---------------|
| 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) | Color
Code |
|----------------------|------------------|----------------|-------------------------|---------------|
| 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) | Color
Code |
|--------------------------|------------------|----------------|-------------------------|---------------|
| 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

6

| Manufacturer Numbers | Jaw O.D.
(mm) | Length
(cm) | Working Channel
(mm) | Color
Code |
|----------------------|------------------|----------------|-------------------------|---------------|
| 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 |

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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 .

:

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 |

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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
1268
with needle	14 4 6		ﺎ	Rue
1760
with needle
A 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

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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

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

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