REPROCESSED HARMONIC SHEAR by STERILMED, INC.

The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleeding and minimal thermal injury is desired. The instruments can be used as un udjunct to or a substitute for clectrosurgery, lasers, and steel scalpels in general, plastic, pediatic, gyncoologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Device Description

The harmonic shears are used in combination with a handpiece, generator and torque wrench and are intended to be used for cutting and coagulation of soft tissue during laparoscopic and open procedures. The instruments allow the surgeon to grasp, coagulate and cut soft tissue with one instrument. The instruments allow for the coagulation of vessels up to and including 5 mm in diameter. The instruments are hand-actuated with a shaft and distal tip that can be rotated 360°. The ultrasonic energy is delivered by hand activation or with an optional generator foot switch.

AI/ML Overview

The provided document pertains to the reprocessed Harmonic Shears and does not describe a study involving an AI device or its acceptance criteria. The document is a 510(k) summary for a medical device (reprocessed harmonic shears) and focuses on demonstrating substantial equivalence to predicate devices, rather than the performance of an AI algorithm.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details based on the provided text.

Summary

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II. SUMMARY AND CERTIFICATION

A.	510(k) Summary	K132566		JUN 14 2014
	Submitter:	Sterilmed, Inc.
	Contact Person:	Jason Skramsted11400 73rd Avenue NorthMaple Grove, MN 55369Phone: 763-488-3483Fax: 763-488-4491
	Date Prepared:	14 August 2013
	Trade Name:	Reprocessed Harmonic Shears
	Regulation Name:	Scalpel, Ultrasonic, Reprocessed
	Device Classification:	Unclassified
	Product Code:	NLQ

PredicateDevices:	The reprocessed harmonic shears are substantially equivalent to the Ethicon Harmonic Shears (K121550,K120729 and K060245).
DeviceDescription:	The harmonic shears are used in combination with a handpiece, generator and torque wrench and are intendedto be used for cutting and coagulation of soft tissue during laparoscopic and open procedures. Theinstruments allow the surgeon to grasp, coagulate and cut soft tissue with one instrument. The instrumentsallow for the coagulation of vessels up to and including 5 mm in diameter. The instruments are hand-actuatedwith a shaft and distal tip that can be rotated 360°. The ultrasonic energy is delivered by hand activation orwith an optional generator foot switch.
Intended Use:	The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleedingand minimal thermal injury is desired. The instruments can be used as an adjunct to or a substitute forelectrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic,exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
TechnologicalCharacteristics:	The reprocessed harmonic shears are identical to the predicate devices in design, materials of construction,and intended use. There are no changes to the clinical applications, patient population, performancespecifications, or method of operation.
Functional andSafety Testing:	Representative samples of reprocessed harmonic shears were tested to demonstrate appropriate functionalcharacteristics. Process validation testing was performed to validate the cleaning and sterilization proceduresas well as device packaging. In addition, the manufacturing process includes visual and validated functionaltesting of all products produced.
Summary ofNon-clinicalTestsConducted:	Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<71>), biocompatibility testing (ISO10993), ethylene oxide residual testing (ISO 10993-7), packagingvalidation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980). In addition,validation of functional performance (bench testing) was performed through simulated use, visual inspection.fatigue testing, and function testing. Performance testing shows the reprocessed harmonic shears to performas originally intended.
Conclusion:	Sterilmed concludes that the reprocessed harmonic shears are safe, effective, and substantially equivalent tothe predicate devices, Ethicon Harmonic Shears (K121550, K120729, and K060245), as described in thispremarket notification submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2014

SterilMed % Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73td Avenue, North Maple Grove, Minnesota 55369

Re: K132566

Trade/Device Name: Reprocessed Harmonic Shears (See enclosed list) Regulatory Class: Unclassified Product Code: NLQ Dated: May 20, 2014 Received: May 21, 2014

Dear Mr. Skramsted:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 Régister.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Jason Skramsted

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 – Mr. Jason Skramsted

Model Number	Device Name	ShaftDiameter	ShaftLength
HAR23M	Reprocessed Harmonic Shears	5 mm	23 cm
HAR36M	Reprocessed Harmonic Shears	5 mm	36 cm
ACE23E	Reprocessed Harmonic Shears	5 mm	23 cm
ACE36E	Reprocessed Harmonic Shears	5 mm	36 cm
N/A	Reprocessed Torque Wrench	N/A	N/A

: 上一篇:

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Indications for Use

510(k) Number (if known): K132566

Device Name: Reprocessed Harmonic Shears

Indications for Use:

Prescription Use X (Part 2) CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ua C. N

Regulation Number and Section

N/A