← Product Code NLQ · K012571 # REPROCESSED HARMONIC (K012571) _Sterilmed, Inc. · NLQ · Nov 7, 2001 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K012571 ## Device Facts - **Applicant:** Sterilmed, Inc. - **Product Code:** NLQ - **Decision Date:** Nov 7, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic, Pediatric ## Intended 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. ## Device Story Reprocessed ultrasonic scalpel system components (handle and blade) used for simultaneous soft tissue cutting and hemostasis. Device functions as part of an ultrasonic system including generator, foot switch, and hose (not included in submission). Reprocessed by SterilMed, Inc. to restore functionality of single-use devices. Used in surgical settings (abdominal, pediatric, gynecological, endoscopic) by surgeons. Provides mechanical ultrasonic energy for tissue interaction; benefits include reduced thermal injury compared to traditional electrosurgery. Reprocessing involves cleaning, sterilization, and functional/visual testing to ensure performance equivalent to original manufacturer devices. ## Clinical Evidence Bench testing only. Representative samples underwent functional testing. Process validation performed for cleaning, sterilization, and packaging. Manufacturing process includes 100% visual and functional testing of all reprocessed units. ## Technological Characteristics Materials: aluminum with nickel chrome alloy edge or titanium alloy (with/without coating). Ultrasonic energy source. Various lengths, circumferences, angles, and sharpness. Reprocessed single-use components (handle and blade). ## Regulatory Identification Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). ## Predicate Devices - Harmonic Scalpel Hs2 Blade ([K941897](/device/K941897.md)) - Reusable Laparosonic Blade System ([K930352](/device/K930352.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ Reprocessed Ultrasonic Scalpel Models found to be Substantially Equivalent: - 1. Ethicon, HDH05 - 2. Ethicon, HSH05 - Ethicon, HBC05 3. - 4. Ethicon, HC325 - 5. Ethicon, DH010 - Ethicon, DSH10 6. - 7. Ethicon, DBC10 - Ethicon, DH105 8. - Ethicon, DH145 9. - 10. Ethicon, HC105 - 11. Ethicon, SH105 - 12. Ethicon, SH145 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K012571 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 {4}------------------------------------------------ ## NOV 0 7 2001 ## SECTION 2. SUMMARY AND CERTIFICATION ## 510(k) Summary A. | Submitter: | SterilMed, Inc. | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Patrick Fleischhacker
11400 73rd Avenue North
Minneapolis, MN 55369
Ph: 763-488-3400
Fax: 763-488-3350 | | Date Prepared: | August 7, 2001 | | Trade Name: | Reprocessed Harmonic Scalpels | | Classification Name: | Electrosurgical cutting and coagulation device and
Accessories | | Classification Number: | 21 CFR 878.4400 | | Product Code: | LFL | | Predicate Device(s): | The reprocessed harmonic scalpel is substantially
equivalent to the 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. | | Device Description: | 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. | Premarket Notification . . {5}------------------------------------------------ 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: --- **Source:** [https://fda.innolitics.com/device/K012571](https://fda.innolitics.com/device/K012571) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com