(295 days)
Not Found
NOT FOUND
No
The description focuses on the mechanical aspects and intended use of a physical biopsy tool, with no mention of software, algorithms, or data processing related to AI/ML.
No.
therapeutic device is used to treat a disease, injury, or other condition. This device is used for diagnostic purposes by collecting tissue samples.
No
The device is used to collect tissue samples for histologic examination, which is a step in the diagnostic process, but the device itself does not perform the diagnosis. It is a tool for sample collection, not for analysis or interpretation of data to arrive at a diagnosis.
No
The device description clearly outlines physical components such as a handle, coil, spring, rod mechanism, and biopsy jaws, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect tissue samples for histologic examination" during endoscopic procedures. This describes a device used to obtain a sample from the body, not a device used to test a sample that has already been removed from the body.
- Device Description: The description details a mechanical tool for grasping and cutting tissue. It does not describe reagents, test strips, analyzers, or any other components typically associated with in vitro diagnostic testing.
- Lack of IVD Keywords: The document does not mention any terms related to in vitro testing, such as "assay," "reagent," "analyte," "diagnosis," "laboratory," or "testing of samples."
- Performance Studies: The performance studies described focus on the functional characteristics of the forceps (bench testing) and the reprocessing procedures (cleaning and sterilization). These are relevant to the safety and efficacy of a surgical/sampling tool, not an IVD.
In summary, the device is a tool for collecting a biological sample, which is then sent for histologic examination (a type of in vitro diagnostic test performed on the collected sample). The forceps themselves are not performing the diagnostic test.
No
The provided FDA clearance letter does not contain any mention of a 'Predetermined Change Control Plan' or 'PCCP'. PCCP-authorized devices are specifically noted in their clearance letters, which is not the case here.
Intended Use / 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.
Product codes
NON
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal 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
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.
Key Metrics
Not Found
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.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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-
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:
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1988 - 1
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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)