(90 days)
The Reprocessed Harmonic Scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.
Harmonic scalpels are part of an ultrasonic system and are intended to be used in soft tissue surgery for simultaneous cutting and hemostasis. The system consists of a generator/foot switch, handle, connecting hose, and a scalpel blade. Only the handle and scalpel blade are reprocessed. The generator/foot switch and hose components of the device are not included as part of this submission. Harmonic scalpels can be manufactured using aluminum with a nickel chrome alloy edge or a titanium alloy (with or without a coating.) These scalpels are available in a variety of lengths, outer circumferences, angles, and sharpness.
This document is a 510(k) clearance letter from the FDA for reprocessed ultrasonic scalpels, specifically addressing a supplemental validation submission. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are not applicable to this document.
The document discusses:
- Device: Reprocessed Ultrasonic Scalpel (various Ethicon models listed).
- Clearance: The FDA has determined the reprocessed devices are substantially equivalent to legally marketed predicate devices.
- Validation: It mentions that supplemental validation data was provided as required for reprocessed single-use devices, and "bench testing to demonstrate appropriate functional characteristics" and "process validation testing for cleaning and sterilization" were performed. However, specific acceptance criteria and detailed performance results from these tests are not provided in this letter.
- Indications for Use: Soft tissue incisions when bleeding control and minimal thermal injury are desired.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Bruce Lester Vice President, Research and Development SterilMed, Inc. 11400 73rd Ave. North Minneapolis, Minnesota 55369
NOV 1 2004
Re: K012571 - Supplemental Validation Submission Trade/Device Name: Reprocessed Ultrasonic Scalpel (See enclosed list) Regulatory Class: Unclassified Product Code: NLQ Dated: August 7, 2001 Received: August 9, 2001
Dear Dr. Lester:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 7, 2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices 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 devices comply 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 applicable 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 - Dr. Bruce Lester
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Miriam C. Provost
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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Reprocessed Ultrasonic Scalpel Models found to be Substantially Equivalent:
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- Ethicon, HDH05
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- Ethicon, HSH05
- Ethicon, HBC05 3.
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- Ethicon, HC325
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- Ethicon, DH010
- Ethicon, DSH10 6.
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- Ethicon, DBC10
- Ethicon, DH105 8.
- Ethicon, DH145 9.
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- Ethicon, HC105
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- Ethicon, SH105
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- Ethicon, SH145
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Indications for Use
510(k) Number (if known):
Device Name:
Reprocessed Harmonic Scalpels
Indications For Use:
The Reprocessed Harmonic Scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.
Prescription Use_ × (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)
iriam C. Provost
Division of General, Restorative, and Neurological Devices
Page 1 of _
510(k) Number K012571
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NOV 0 7 2001
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Patrick Fleischhacker11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 763-488-3400Fax: 763-488-3350 |
| Date Prepared: | August 7, 2001 |
| Trade Name: | Reprocessed Harmonic Scalpels |
| Classification Name: | Electrosurgical cutting and coagulation device andAccessories |
| Classification Number: | 21 CFR 878.4400 |
| Product Code: | LFL |
| Predicate Device(s): | The reprocessed harmonic scalpel is substantiallyequivalent to the Harmonic Scalpel Hs2 Blade (K941897),manufactured by Ethicon (formerly Ultracision); ReusableLaparosonic Blade System (K930352), manufactured byEthicon (formerly Ultracision); and the counterpart devicesfrom the original manufacturer. |
| Device Description: | Harmonic scalpels are part of an ultrasonic system and areintended to be used in soft tissue surgery for simultaneouscutting and hemostasis. The system consists of agenerator/foot switch, handle, connecting hose, and ascalpel blade. Only the handle and scalpel blade arereprocessed. The generator/foot switch and hosecomponents of the device are not included as part of thissubmission.Harmonic scalpels can be manufactured using aluminumwith a nickel chrome alloy edge or a titanium alloy (with orwithout a coating.) These scalpels are available in a varietyof lengths, outer circumferences, angles, and sharpness. |
Premarket Notification
.
.
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The reprocessed harmonic scalpels are intended for use in Intended Use: soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.
Representative samples of reprocessed harmonic scalpels 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 reprocessed.
The reprocessed harmonic scalpel is substantially equivalent to Harmonic Scalpel Hs2 Blade (K941897), manufactured by Ethicon (formerly Ultracision); Reusable Laparosonic Blade System (K930352), manufactured by Ethicon (formerly Ultracision); and the counterpart devices from the original manufacturer. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.
Conclusion:
Functional and
Safety Testing:
N/A