(295 days)
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.
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.
The provided document is a 510(k) summary for SterilMed's Reprocessed Cold Biopsy Forceps. This submission is for a reprocessed medical device, not a novel AI/software-as-a-medical-device (SaMD) or diagnostic device that relies on algorithms for analysis or detection. Therefore, many of the typical questions regarding acceptance criteria and study design for AI-based devices are not applicable.
This document describes the functional and safety testing to demonstrate that the reprocessed devices perform equivalently to their original manufactured counterparts and predicate devices.
Here's an analysis based on the information provided, specifically addressing the questions where applicable, and noting where information is not present given the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document states that "Reprocessed Cold Biopsy Forceps underwent bench testing to demonstrate appropriate functional characteristics." It also mentions "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."
However, specific numerical acceptance criteria (e.g., tensile strength, bite completeness, cleanliness levels) and quantitative performance results are not detailed in this summary. The conclusion broadly states that the reprocessed forceps are "substantially equivalent" based on "similarities in functional design, materials, indications for use and methods of construction."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Representative samples" were used for bench testing. It does not specify the exact sample size for the functional and safety testing. Given it's a medical device reprocessing submission, the "data provenance" would refer to the testing results of the reprocessed devices themselves, rather than clinical data from human subjects. The testing described is prospective in nature as it's performed on reprocessed devices to validate the process. There is no mention of country of origin of the data beyond the submitter's location (Minneapolis, MN, USA).
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 question is not applicable to this submission. The "ground truth" for the performance of a reprocessed biopsy forceps would be its ability to safely and effectively retrieve tissue samples, as demonstrated through functional and safety testing. There are no "experts" establishing ground truth in the sense of image interpretation or medical diagnosis as would be relevant for an AI/diagnostic device. The "ground truth" is typically defined by engineering specifications and performance benchmarks compared to new devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for diagnostic devices to resolve discrepancies in interpretations. For functional bench testing of a reprocessed mechanical device, direct physical measurements and observations are used, not expert adjudication of interpretations.
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
This question is not applicable as this is a submission for a reprocessed medical device, not an AI/SaMD. There are no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical biopsy forceps; it does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for the functional and safety testing would be adherence to established engineering specifications and performance characteristics of new, equivalent devices, as well as the sterility and cleanliness standards required for a reprocessed device. This relies on benchmarking against predicate devices and validated manufacturing/reprocessing specifications, rather than expert consensus on medical images or pathology.
8. The sample size for the training set
This question is not applicable as this is not an AI/machine learning device. There is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/machine learning device. There is no "training set" or ground truth establishment as it would apply to AI.
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K042648
Page 1 of 2
SECTION 2. SUMMARY AND CERTIFICATION
2.A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce LesterSterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 763-488-3400Fax: 763-488-3350 |
| Date Prepared: | September 26, 2004 |
| Trade Name: | Reprocessed Cold Biopsy Forceps |
| Classification Name:and Number: | Gastroenterology-Urology Biopsy InstrumentsClass I, 21 CFR 876.1075 |
| Product Code: | NON |
| Predicate Device(s): | The reprocessed cold biopsy forceps are substantiallyequivalent to the Precisor EXL Cold biopsy Forcepsmanufactured by Bard and the Radial Jaw 3 Cold biopsyforceps manufactured by Microvasive. Both of thepredicate devices are Class 1 devices. |
| Device Description: | The device consists of a proximal handle which isconnected, via a coil, spring or rod mechanism, to thebiopsy jaws at the distal tip. The biopsy forceps range from100 to 240cm in length and 1.8-3.3mm in diameter. Thejaws range from 1.8 to 3.3mm in diameter. The jaws of theforceps may or may not have serrated edges, a fenestration,needle, or distal biting tooth. |
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K042648
Page 2 of 2
| Intended Use: | The Reprocessed Cold Biopsy Forceps are intended to beused during endoscopic procedures of the gastrointestinaltract to collect tissue samples for histologic examination.These forceps are advanced to the site for sampling via theoperating channel of an endoscope. |
|---|---|
| Functional andSafety Testing: | Representative samples of reprocessed cold biopsy forcepsunderwent bench testing to demonstrate appropriatefunctional characteristics. Process validation testing wasdone to validate the cleaning and sterilization procedures aswell as the device's packaging. In addition, themanufacturing process includes visual and functionaltesting of all products produced. |
| Conclusion: | The cold biopsy forceps reprocessed by SterilMed aresubstantially equivalent to their counterparts from theoriginal manufacturers and to the Precisor EXL ColdBiopsy Forceps manufactured by Bard and the Radial Jaw3 Cold biopsy forceps manufactured by Microvasive. Thisconclusion is based upon the devices' similarities infunctional design, materials, indications for use andmethods of construction. |
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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.
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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
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| OriginalManufacturer(BARD) | Cup Type | Jaw Size (mm) | Length (cm) |
|---|---|---|---|
| ManufacturerNumber | |||
| 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 |
| OriginalManufacturer(Microvasive)ManufacturerNumber | 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 |
| OriginalManufacturer(Wilson-Cook) | Cup Type | Jaw Size (mm) | Length (cm) |
| ManufacturerNumber | |||
| 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
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Table 2 - Microvasive Cold Biopsy Forceps to be Reprocessed
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: 上一篇:
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Table 3 - Wilson-Cook Cold Biopsy Forceps to be Reprocessed
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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)
§ 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.