(157 days)
Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.
SterilMed's reprocessed electrosurgical electrodes are a monopolar electrosurgical instruments consisting of a tungsten tip, stainless steel housing, and several layers of insulation.
The provided text is a 510(k) summary for SterilMed's Reprocessed Electrosurgical Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, many of the requested items (e.g., AI performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies) are not applicable to this submission.
Here's an analysis of the available information:
Device: SterilMed Reprocessed Electrosurgical Electrodes
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating that the reprocessed device performs comparably to new, equivalent devices and meets safety standards for reuse. The submission emphasizes substantial equivalence rather than numerical performance against specific criteria.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence (e.g., cutting, cauterizing ability) | "Representative samples of reprocessed electrosurgical electrodes underwent bench testing to demonstrate appropriate functional characteristics." "The subject device is identical to their predicate device in terms of functional design... and principles of operation." |
| Cleaning and Sterilization Effectiveness (Safety) | "Process validation testing was done to validate the cleaning and sterilization procedures..." |
| Packaging Integrity (Safety) | "...as well as the device's packaging." |
| Visual and Functional Inspection (Quality Control) | "In addition, the manufacturing process includes visual and functional testing of all products produced." |
| Substantial Equivalence to Predicate Devices | The FDA concurred with the finding of substantial equivalence to: • The Colorado Micro-Dissection Needle manufactured by Stryker Leibinger / Colorado Biomedical Inc (K000348) • Similar devices from other manufacturers This equivalence is based on "functional design, materials, indications for use, and principles of operation." |
2. Sample size used for the test set and the data provenance
The document indicates "representative samples" were used for bench testing. It does not specify a numerical sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not mentioned, as this is a reprocessed medical device submission, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission doesn't involve establishing ground truth from expert interpretations of medical images or data. The "ground truth" here is the functional performance and safety of the reprocessed device, assessed through bench testing and process validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study assessing interpretations of medical data. The evaluation is based on engineering and quality control tests.
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 device is an electrosurgical electrode, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance and safety is established through:
- Bench testing: Verifying functional characteristics (e.g., cutting ability).
- Process validation: Confirming the efficacy of cleaning, sterilization, and packaging procedures.
- Comparison to predicate devices: Demonstrating consistency in design, materials, and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this type of device.
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SECTION 2. SUMMARY AND CERTIFICATION
012684
510(k) Summary A.
| Submitter: | SterilMed, Inc.. |
|---|---|
| Contact Person: | Patrick Fleischhacker11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 888-856-4870Fax: 763-488-3350 |
| Date Prepared: | August 11, 2001 |
| Trade Name: | SterilMed Reprocessed Electrosurgical Electrodes |
| Classification Nameand Number: | Electrosurgical Device, Class II, 21 CFR 878.4400 |
| Product Code: | JOS |
| Predicate Device(s): | SterilMed's Reprocessed electrosurgical electrodes aresubstantially equivalent to:• The Colorado Micro-Dissection Needle manufacturedby Stryker Leibinger / Colorado Biomedical Inc(K000348)• Similar devices from other manufacturers |
| Device Description: | SterilMed's reprocessed electrosurgical electrodes are amonopolar electrosurgical instruments consisting of atungsten tip, stainless steel housing, and several layers ofinsulation. |
| Intended Use: | Reprocessed electrosurgical electrodes are intended forprecision cutting or dissecting and cauterizing soft tissue.These devices are most commonly used in surgicalprocedures for which minimal tissue necrosis, bleeding,and surgical field smoke is desired. |
| Functional andSafety Testing: | Representative samples of reprocessed electrosurgicalelectrodes underwent bench testing to demonstrateappropriate functional characteristics. Process validationtesting was done to validate the cleaning and sterilizationprocedures as well as the device's packaging. In addition, |
:
Premarket Notification
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the manufacturing process includes visual and functional testing of all products produced.
Conclusion:
The electrosurgical electrodes reprocessed by SterilMed are substantially equivalent to:
- The Colorado Micro-Dissection Needle manufactured . by Stryker Leibinger / Colorado Biomedical Inc. (K000348)
- Similar devices from other manufacturers .
This conclusion is based upon the fact that the subject device is identical to their predicate device in terms of functional design, materials, indications for use, and principles of operation.
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OF HEALTH & HUMAN SERVICES.USA
DEPARTMENT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2002
Mr. Patrick Fleischhacker Vice President, Regulatory and Quality Control SterilMed, Inc. 11400 73ª Avenue North Maple Grove, Minnesota 55369
Re: K012684
Trade/Device Name: Reprocessed Electrosurgical Electrodes Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 6, 2001 Received: December 7, 2001
Dear Mr. Fleischhacker:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 such 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.
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Page 2 - Mr. Patrick Fleischhacker
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and w yourse ought finding of substantial equivalence of your device to a legally premated 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 and 11 you assile by controlary 21 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It For 4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general information turers, 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,
Sincerely, yours,
L. Mark M. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use Page
012684
Device Name: Reprocessed electrosurgical electrodes, or reprocessed electrosurgical electrodes.
Indications for Use:
Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and reprocesson crocirous grounds are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ro Mark N Millersen
Division Sign-Off Division of General, Restorative and Neurological Devices
51(c) Number K012684
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.