(77 days)
Not Found
No
The document describes a reprocessed biopsy forceps and its intended use for tissue collection. There is no mention of AI or ML in the intended use, device description, or any other section. The focus is on the reprocessing procedure and the physical characteristics of the device.
No
The device is described as a tool for removing polyps and tissue specimens, and for cauterization (in the case of hot biopsy forceps), which are diagnostic and procedural functions rather than therapeutic.
No
The device is described as an instrument used to physically remove polyps and tissue specimens, which is a therapeutic or interventional action, not a diagnostic one. While the collected tissue might later be used for diagnosis, the device itself is for collection/removal.
No
The device description clearly describes a physical medical device (biopsy forceps) that is reprocessed, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove polyps and/or tissue specimens throughout the alimentary tract" and for "cauterize and remove polyps and/or tissue specimens throughout the alimentary tract." This describes a surgical or procedural tool used in vivo (within the body) to collect samples or perform a procedure.
- Device Description: The description details a physical instrument ("long instruments with a small jaw type mechanism") used for collecting tissue samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, analyzers, or other components used to test biological samples like blood, urine, or tissue in a lab setting.
The device described is a surgical instrument used for tissue collection and/or cauterization during an endoscopic procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
78 KGE, 78 FCL
Device Description
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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 a |
| Class 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.
"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.
Medical Device Services, Reprocessed Used Disposable Biopsy Forceps are substantially equivalent to disposable biopsy forceps currently marketed new by Microvasive under 510(k) 932266.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
| NOV 4 2002 | Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850 |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Medical Device Services
c/o Mr. Mark W. Aldana
President
Adven Medical, Inc.
1001 Slaton Hwy.
LUBBOCK TX 79404 | Re: K022751 |
| | Trade/Device Name: Reprocessed Used Disposable
Biopsy Forceps (SEE ENCLOSURE 1) |
| | Regulation Number: 21 CFR §876.4300 |
| | Regulation Name: Endoscopic electrosurgical unit
and 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.
2
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
3
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) | 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 |
4
| 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 |
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 |
5
| 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 |
. . . .
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 |
6
| 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
7
Page 1 of
510(k) Number:
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)
OR
Over-The-Counter Use (Optional Format 1-2-96)
David A. Szymon
on Sign-Off of Reproductive. Abdominal onical Davies