(86 days)
These devices are designed for general surgical use, including orthopedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissue. Arthroscopic surgery may include the following: Knee, Shoulder, Ankle, Elbow, and Wrist.
SterilMed's reprocessed RF Arthroscopy Probes are radio frequency electrosurgical devices that are designed for arthroscopic surgical procedures and are used with a conductive irrigant. They consist of connector pins, a handle, an insulated cannula, a return electrode, an electrode tip with single or multiple electrodes, and come in straight or angled designs.
The provided text describes a 510(k) summary for SterilMed's Reprocessed RF Arthroscopy Probes. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding performance, sample sizes, expert involvement, and ground truth generation for a clinical study is not detailed in this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics | Representative samples underwent bench testing to demonstrate appropriate functional characteristics. |
| Cleaning Validation | Process validation testing was done to validate the cleaning procedures. |
| Sterilization Validation | Process validation testing was done to validate the sterilization procedures. |
| Packaging Validation | Process validation testing was done to validate the devices' packaging. |
| Manufacturing Process Quality | The manufacturing process includes visual and functional testing of all products produced. |
2. Sample size used for the test set and the data provenance
The document mentions "Representative samples" for bench testing and "all products produced" for manufacturing process testing. It does not specify a distinct "test set" sample size for proving acceptance criteria in a clinical context, nor does it provide information on data provenance (country of origin, retrospective/prospective). This is because the device focuses on reprocessing existing devices, and the testing described is primarily for manufacturing and reprocessing validation, not clinical performance for a novel device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes bench testing and process validation, not a study where expert-established ground truth would be required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a process requiring adjudication.
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-powered diagnostic device, and thus, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device is a reprocessed physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed device is implied to be its functional equivalency to new, legally marketed predicate devices, and the safety and effectiveness of its reprocessing. This is assessed through:
- Bench testing: Against performance specifications derived from the predicate devices.
- Process validation: To ensure cleaning, sterilization, and packaging meet established standards.
- Visual and functional testing: During manufacturing.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study:
The study described is not a clinical trial or performance study against specific diagnostic or treatment outcomes. Instead, it is a validation study for a reprocessed medical device. The primary goal was to demonstrate substantial equivalence to original, legally marketed devices.
The study involved:
- Bench testing: On "representative samples" to confirm functional characteristics.
- Process validation: To ensure the efficacy of cleaning, sterilization, and packaging procedures.
- Manufacturing quality checks: Including visual and functional testing of "all products produced."
The conclusion of the study was that the reprocessed RF Arthroscopy Probes are substantially equivalent to the predicate devices based on "functional design, materials, indications for use, and principles of operation." The FDA concurred with this finding, allowing the device to be marketed.
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K 012679
NOV 0 8 2001 SECTION 2. SUMMARY AND CERTIFICATION
| A. 510(k) Summary | |
|---|---|
| Submitter: | SterilMed, Inc. |
| Contact Person: | Patrick Fleischhacker11400 73 rd Avenue NorthMinneapolis, MN 55369Ph: 888-856-4870Fax: 763-488-3350 |
| Date Prepared: | August 11, 2001 |
| Trade Name: | SterilMed Reprocessed RF Arthroscopy Probes |
| Classification Name and Number: | Electrosurgical Device, Class II, 21 CFR 878.4400, and21 CFR 888.1100 |
| Product Code: | GEI and HRX |
| Predicate Device(s): | SterilMed's Reprocessed RF Arthroscopy Probes aresubstantially equivalent to the Arthroscopy Probes packagedwith:ArthroCare Corp.'s ArthroCare Orthopedic Electrosurgery System (K992581);Oratec Interventions, Inc.'s VulcanTM EASTM ElectroThermal Arthroscopy System and Accessories (K991140);Mitek ® Products Vapr TM System and Accessory Electrosurgical Electrodes (K974022) (K992876) (K002422); andTo their counterparts from the original manufacturers. |
| Device Description: | SterilMed's reprocessed RF Arthroscopy Probes are radio frequency electrosurgical devices that are designed for arthroscopic surgical procedures and are used with a conductive irrigant. They consist of connector pins, a handle, an insulated cannula, a return electrode, an electrode tip with single or multiple electrodes, and come in straight or angled designs. |
| Intended Use: | These devices are designed for general surgical use, including orthopedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels, and |
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| coagulation of soft tissue. Arthroscopic surgery may include the following: Knee, Shoulder, Ankle, Elbow, and Wrist. | |
|---|---|
| Functional andSafety Testing: | Representative samples of reprocessed RF Arthroscopy Probes underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the devices packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. |
| Conclusion: | The RF Arthroscopy Probes reprocessed by SterilMed are substantially equivalent to the Arthroscopy Probes packaged with:ArthroCare Corp.'s ArthroCare Orthopedic Electrosurgery System (K992581); Oratec Interventions, Inc.'s VulcanTM EASTM ElectroThermal Arthroscopy System and Accessories (K991140); Mitek® Products VaprTM System and Accessory Electrosurgical Electrodes (K974022) (K992876) (K002422); and To their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices' are essentially identical to their predicate devices in terms of functional design, materials, indications for use, and principles of operation |
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 8 2001
Mr. Patrick Fleischhacker Vice President of Regulatory and Quality Control SterilMed, Inc. 11400 73ª Avenue North Minneapolis, Minnesota 55369
Re: K012679
Trade/Device Name: SterilMed Reprocessed RF Arthroscopy Probes Regulation Number: 878.4400, 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories Arthroscope Regulatory Class: II Product Code: GEI, HRX Dated: August 11, 2001 Received: August 14, 2001
Dear Mr. Fleischhacker:
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 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) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR 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,
Lisa Walker, in
Image /page/3/Picture/5 description: The image contains a handwritten letter 'E' in a simple, slightly stylized font. The letter is black and appears to be drawn with a thick marker or pen, giving it a bold appearance. The background is plain and white, which makes the letter stand out.
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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NOV 0 8 2001
Indications for use Page
Device Name: Reprocessed RF Arthroscopy Probes
Indications for Use:
These devices are designed for general surgical use, including orthopedic and These dovices are accipito for ection, ablation, excision of soft tissue, hemostasis of arthroscopic approation of soft tissue. Arthroscopic surgery may include:
K 012679
- Knee .
- Shoulder ●
- Ankle .
- Elbow
- Wrist
Concurrence of CDRH; Office of Device Evaluation (ODE)
Susan Walk
(Division Sign-Off) Division of Cneral, Restorative and Neurological Devices
510(k) Number K012679
1
§ 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.