(180 days)
The Reprocessed Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.
The device consists of a proximal handle containing an electrosurgical plug which is connected, via a coil, spring or rod mechanism, to the biopsy cup or alligator forceps at the distal tip. The biopsy forceps range from 160 to 240 cm in length and 2.2-2.5 mm in diameter. The jaws range from 2.2 to 2.5 mm in diameter. The cup forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth. The forceps are covered with a sheath of electrical insulation. The electrosurgical plug on the handle used for connection to the appropriate electrosurgical unit. This submission does not include the electrosurgical box that the forceps connect to or its associated connecting cable.
The provided document describes a 510(k) summary for "Reprocessed Hot Biopsy Forceps" by SterilMed, Inc. It outlines the device's description, intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information typically found in acceptance criteria tables or detailed study results for AI/ML device performance.
Specifically, the document focuses on regulatory approval for a reprocessed medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies is absent from this regulatory submission.
The "Functional and Safety Testing" section vaguely states that "Representative samples of reprocessed hot biopsy forceps underwent bench testing to demonstrate appropriate functional characteristics." This is a high-level summary and does not provide specific performance metrics or detailed study designs.
Therefore, I cannot provide the requested information for an AI/ML device based on the given input.
Should the request pertain to the reprocessed hot biopsy forceps themselves (as a non-AI device), the relevant information from the document is summarized below, but it does not fit the typical format for AI/ML device performance evaluation criteria.
Based on the provided document, here's what can be extracted regarding the device and its testing, keeping in mind it's for a reprocessed physical medical device, not an AI/ML system:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/ML device. Instead, it refers to "appropriate functional characteristics" for a reprocessed physical device.
| Acceptance Criteria (Implied for Reprocessed Hot Biopsy Forceps) | Reported Device Performance (as stated in the document) |
|---|---|
| Maintenance of appropriate functional characteristics | Representative samples underwent bench testing to demonstrate appropriate functional characteristics. |
| Validation of cleaning and sterilization procedures | Process validation testing was done to validate the cleaning and sterilization procedures. |
| Validation of device's packaging | Process validation testing was done to validate the device's packaging. |
| Visual and functional testing as part of manufacturing process | The manufacturing process includes visual and functional testing of all products produced. |
| Substantial Equivalence to Predicate Devices | Concluded to be substantially equivalent to four specific predicate devices 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:
- Sample Size for Test Set: The document states "Representative samples" but does not provide a specific number for the bench testing or process validation.
- Data Provenance: Not specified, but generally, such testing would be conducted in a controlled lab environment by the manufacturer (SterilMed, Inc., Minneapolis, MN, USA). The studies are inherently prospective in the sense that they are performed on the reprocessed devices prior to market release, but the data used to inform the reprocessing protocol might stem from retrospective analysis of failed devices or historical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. For a physical device, "ground truth" often refers to engineering specifications, industry standards, or performance benchmarks established at the time of original manufacturing. It's not typically established by human "experts" in the same way as an AI/ML diagnostic system.
4. Adjudication method for the test set:
Not applicable and not mentioned.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a physical reprocessed device, the "ground truth" is implied to be:
- Engineering specifications of the original device.
- Performance benchmarks (e.g., electrical integrity, mechanical strength, sterility, cleanliness) that allow the device to function as intended and safely.
- Regulatory standards for reprocessing in terms of cleanliness, sterilization, and function.
8. The sample size for the training set:
Not applicable/not specified. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the ground truth for the training set was established:
Not applicable/not specified. There is no "training set" for an AI/ML algorithm.
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JUL 2 0 2005
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SUMMARY AND CERTIFICATION SECTION 2.
2.A. 510(K) SUMMARY
.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce R. LesterSterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 763-488-3400Fax: 763-488-3350 |
| Date Prepared: | January 19, 2005 |
| Trade Name: | Reprocessed Hot Biopsy Forceps |
| Classification Name:and Number: | Electric Biopsy ForcepsClass II, 21 CFR 876.4300 |
| Product Code: | NLU |
| Predicate Device(s): | The reprocessed hot biopsy forceps are substantiallyequivalent to: "Thermal Option" Hot Biopsy Forceps(K932790), manufactured by Ballard (formerly Cox); "TheShark" Hot Biopsy Forceps manufactured by Wilson-Cook(K923470); "Radial Jaw" Hot Biopsy Forceps (K860366),manufactured by Microvasive; and "Precisor" Hot BiopsyForceps (K905088), manufactured by Bard (formerlyESCO). |
| Device Description: | The device consists of a proximal handle containing anelectrosurgical plug which is connected, via a coil, springor rod mechanism, to the biopsy cup or alligator forceps atthe distal tip. The biopsy forceps range from 160 to 240cm in length and 2.2-2.5 mm in diameter. The jaws rangefrom 2.2 to 2.5 mm in diameter. The cup forceps may ormay not have serrated edges, a fenestration, needle, ordistal biting tooth. |
| The forceps are covered with a sheath of electricalinsulation. The electrosurgical plug on the handle used forconnection to the appropriate electrosurgical unit. Thissubmission does not include the electrosurgical box that theforceps connect to or its associated connecting cable. | |
| Intended Use: | The reprocessed hot biopsy forceps are intended to be usedfor endoscopic tissue sample acquisition, controlledcoagulation/cautery, and sessile polyp removal in thegastrointestinal tract. |
| Functional andSafety Testing: | Representative samples of reprocessed hot 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 hot biopsy forceps reprocessed by SterilMed aresubstantially equivalent to the following specific predicatedevices: "Thermal Option" Hot Biopsy Forceps (K932790),manufactured by Ballard (formerly Cox); "The Shark" HotBiopsy Forceps manufactured by Wilson-Cook (K923470);"Radial Jaw" Hot Biopsy Forceps (K860366),manufactured by Microvasive; and "Precisor" Hot BiopsyForceps (K905088), manufactured by Bard (formerlyESCO). This conclusion is based upon the devices'similarities in functional design, materials, indications foruse and methods of construction. |
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Image /page/2/Picture/2 description: The image shows a logo with a stylized bird figure. The bird is depicted with three curved lines forming its body and wings. The logo also includes text arranged in a circular pattern around the bird, although the specific text is not clear due to the image quality. The overall design is simple and abstract.
JUL 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bruce R. Lester, Ph.D. Vice President of R&D SterilMed, Inc. 11400 73rd Avenue North MAPLE GROVE MN 55369
Re: K050136
Trade/Device Name: SterilMed Reprocessed Hot Biopsy Forceps (see enclosure) Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLU Dated: April 27, 2005 Received: April 28, 2005
Dear Dr. Lester:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have route determined the device is substantially equivalent (for the indications for use stated in above and have as a legally marketed predicate devices marketed in interstate commerce prior to the cholors, the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1710, and classified in accordans of the Federal Food, Drug, and Cosmetic Act (Act) that tecassinod in accordatios approval application (PMA). You may, therefore, market the do not require approvations of the Act. The general controls provisions of the Act. device, subjoc to 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 (Premarket If your device is older to such additional controls. Existing major regulations affecting your Approval), a the you be boor 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 I caral statues and rogalding, 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) (2) CFR Part 807); 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) I ms letter with anow you to ogin manenes of your device of your device to a legally premarked nothleation: "The PDF mailig sification 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 If you desire specific auvice tor your acrees on 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 premarket notification" (21 CFR Also, please note the regulation entitled, " have the on your responsibilities under the Act from the 807.97). Tou Inay Outain other general 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/industry/support/index.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
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Attachment - Reprocessed Hot Biopsy Forceps (K050136)
| Bard |
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| 000852 |
| 000853 |
| 000854 |
| 000856 |
| Ballard |
| 60101 |
| 60102 |
| 60103 |
| 60104 |
| 60107 |
| 60108 |
| 60109 |
| 60110 |
| 60113 |
| 60114 |
| 60115 |
| 60116 |
| 60119 |
| 60120 |
| 60121 |
| 60122 |
| Microvasive |
1 250
Wilson-Cook
HS-2.5-230 HDS-2.5-230
'문관 1
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Indications for Use
| 510(k) Number (if known): | K050136 |
|---|---|
| Device Name: | Reprocessed Hot Biopsy Forceps |
| Indications For Use: |
The Reprocessed Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Darrey C. hagdon
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 0501-510(k) Number _
§ 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).