REPROCESSED HARMONIC SCALPELS

K050343 · Sterilmed, Inc. · NLQ · Apr 12, 2005 · SU

Device Facts

• Record ID: K050343
• Device Name: REPROCESSED HARMONIC SCALPELS
• Applicant: Sterilmed, Inc.
• Product Code: NLQ · SU
• Decision Date: Apr 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• 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 scalpels; used in soft tissue surgery for simultaneous cutting and hemostasis. System components include generator/foot switch, handle, connecting hose, and scalpel blade; SterilMed reprocesses only handle and blade. Scalpels constructed from aluminum with nickel chrome alloy edge or titanium alloy (with/without coating). Used in OR/endoscopic settings by surgeons. Device provides mechanical ultrasonic energy for tissue interaction; replaces or supplements electrosurgery, lasers, or steel scalpels. Benefits include reduced thermal injury and effective bleeding control.

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 products.

Technological Characteristics

Materials: aluminum with nickel chrome alloy edge or titanium alloy (with/without coating). Sensing/Actuation: ultrasonic energy for cutting/hemostasis. Form factor: various lengths, circumferences, angles, and sharpness. Sterilization: validated cleaning and sterilization processes.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury in abdominal, pediatric, gynecological, and endoscopic procedures.

Regulatory Classification

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)
• Reusable Laparosonic Blade System (K930352)

Submission Summary (Full Text)

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JUN 2 - 2005

Food and Drug Administration 9200 CorporateBoulevard Rockville MD 20850

Dr. Bruce R. Lester Vice President, Research and Development SterilMed Incorporated 11400 73td Avenue North Minneapolis, Minnesota 55369

Re: K050343

Trade/Device Name: Reprocessed Ultrasonic Scalpel (See enclosed list) Regulatory Class: Unclassified Product Code: NLQ Dated: April 12, 2005 Received: April 12,2005

Dear Dr. Lester:

This letter corrects our substantially equivalent letter of April 12, 2005 regarding the omission of a list of the cleared reprocessed ultrasonic scalpel models.

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 (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 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.

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Page 2 - Bruce R. Lester, Ph.D.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http:Nwww.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. A. F.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 – Bruce R. Lester, Ph.D.

Reprocessed Ultrasonic Scalpel Models found to be Substantially Equivalent:

- 1. Ethicon, LCS15
- 2. Ethicon, LCS16
- 3. Ethicon, LCS1S
- 4. Ethicon, LCS6S
- 5. Ethicon, CS150
- 6. Ethicon, CS151
- 7. Ethicon, CS1S
- 8. Ethicon, CS6S

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APR 12 2005
K050343 (pg 1 of 2)

## SECTION 2. SUMMARY AND CERTIFICATION

## 2.A. 510(K) SUMMARY

| Submitter: | SterilMed, Inc. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Bruce R. Lester<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 763-488-3400<br>Fax: [phone] |
| Date Prepared: | February 9, 2005 |
| Trade Name: | Reprocessed Harmonic Scalpels |
| Classification Name: | Electrosurgical cutting and coagulation device and<br>accessories |
| Classification Number: | Class II, 21 CFR 878.4400 |
| Product Code: | NLQ |
| Predicate Device(s): | The reprocessed harmonic scalpels are substantially<br>equivalent to Harmonic Scalpel Hs2 Blade (K941897),<br>manufactured by Ethicon (formerly Ultracision) and<br>Reusable Laparosonic Blade System (K930352),<br>manufactured by Ethicon (formerly Ultracision). |
| Device Description: | Harmonic scalpels are part of an ultrasonic system and are<br>intended to be used in soft tissue surgery for simultaneous<br>cutting and hemostasis. The system consists of a<br>generator/foot switch, handle, connecting hose, and a<br>scalpel blade. Only the handle and scalpel blade are<br>reprocessed. The generator/foot switch and hose<br>components of the device are not included as part of this<br>submission.<br><br>Harmonic scalpels can be manufactured using aluminum<br>with a nickel chrome alloy edge or a titanium alloy (with or<br>without a coating). These scalpels are available in a variety<br>of lengths, outer circumferences, angles and sharpness. |

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K050343 (pg 2 of 2)

Intended Use:

Functional and

Safety Testing:

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.

Representative samples of 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 produced.

The harmonic scalpels reprocessed by SterilMed are substantially equivalent to the following specific predicate devices: Harmonic Scalpel Hs2 Blade (K941897), manufactured by Ethicon (formerly Ultracision) and Reusable Laparosonic Blade System (K930352), manufactured by Ethicon (formerly Ultracision). This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.

Conclusion: