The Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Device Description

The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.

AI/ML Overview

The provided text describes the regulatory clearance for a reprocessed medical device, specifically the "Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology." It details the device's indications for use, its characteristics, and the non-clinical tests performed to demonstrate its substantial equivalence to an original predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and reported performance in the format typically seen for AI device studies (e.g., sensitivity, specificity thresholds). Instead, for this reprocessed surgical instrument, the acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs as "originally intended" and is "substantially equivalent" to the original predicate device through a series of functional, safety, and sterilization tests.

From the "Summary of Non-Clinical Tests Conducted" section, the performance tests conducted include:

Test Performed	Reported Device Performance
Grasping Force	Performed and found to be equivalent
Artery Seal Burst and Tissue Adhesion	Performed and found to be equivalent
Vein Seal Burst and Tissue Adhesion	Performed and found to be equivalent
Electrical and Thermal Safety IEC 60601	Performed and found to be equivalent
Tissue (Jaw) Pad Life	Performed and found to be equivalent
Tissue (Jaw) Pad Removal Force	Performed and found to be equivalent
Thermal Spread and Transection Time	Performed and found to be equivalent
Cleaning Validation	Validated
Sterilization Verification	Verified
Ethylene Oxide Residual Testing (ISO 10993-7)	Performed and found to be compliant
Packaging Validation (ASTM D4169, ASTM F88, ASTM F2096)	Validated
Shelf-Life Validation (ASTM 1980-07)	Validated
Biocompatibility Testing (ISO 10993-1)	Compliant (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity)

The overall conclusion states: "Performance testing shows the Harmonic FOCUS Shears + Adaptive Tissue Technology performs as originally intended." and "Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each performance test. It mentions "Reprocessed devices were tested" and "Each device and accessory are marked and tracked through the reprocessing cycle." The testing appears to be conducted on samples of the reprocessed devices. The provenance is not explicitly stated in terms of country of origin of data or whether it was retrospective or prospective. It is implied to be prospective testing of reprocessed devices manufactured by SterilMed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a physical medical device, not an AI or imaging device that requires expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The performance is assessed through objective engineering and biological tests, not human interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is objective performance testing of a physical device, not an interpretative task 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 or imaging device, and there is no human reader component. The study compares the performance of the reprocessed device against its original predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical surgical instrument, not an algorithm. The "standalone performance" in this context refers to the device's functional integrity and safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's reprocessed performance is established by:

Predicate Device Performance: The original HARMONIC FOCUS® Shears + Adaptive Tissue Technology (Ethicon K133314) serves as the benchmark for expected performance.
Accepted Standards: Compliance with various international and national standards (e.g., ISO 10993-7, ISO 10993-1, IEC 60601, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-07) for sterilization, biocompatibility, packaging, and electrical safety.
Engineering Specifications: The device's original design specifications for grasping force, seal burst, tissue adhesion, jaw pad life, removal force, thermal spread, and transection time.

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, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 15, 2019

SterilMed, Inc. Jan Flegeau Associate Director, Regulatory Affairs 5010 Cheshire Parkway N. Suite 2 Plymouth, Minnesota 55446

Re: K190610

Trade/Device Name: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Regulatory Class: Unclassified Product Code: NLQ Dated: March 7, 2019 Received: March 11, 2019

Dear Jan Flegeau:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Reprocessed Single-Use Device Models Subject to Clearance:

OEMModelNumber	Device Name/Description	OriginalManufacturer	ReprocessedModelNumber
HAR9F	Harmonic FOCUS Shears + Adaptive Tissue Technology	Ethicon	HAR9FR

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190610

Device Name

Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Reprocessed Single-Use Device Models Subject to Clearance:

OEMModelNumber	Device Name/Description	OriginalManufacturer	ReprocessedModelNumber
HAR9F	Harmonic FOCUS Shears + Adaptive Tissue Technology	Ethicon	HAR9FR

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510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Date Prepared:	August 2, 2019
Submitter andManufacturer:	Sterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446www.sterilmed.com
ManufacturingFacility Address:	11400 73rd AvenueNorth Maple GroveMN 55369
OfficialCorrespondent:	Jan FlegeauAssociate Director, Regulatory AffairsSterilMed, Inc.Tel: 786-575-5903Email: jflegeau@its.jnj.com
Trade Name:	Reprocessed HARMONIC FOCUS® Shears + Adaptive TissueTechnology
Regulation Name:	Scalpel, Ultrasonic, Reprocessed
Device Classification:	Unclassified
Product Code	NLQ
Predicate Device:	HARMONIC FOCUS® Shears + Adaptive Tissue Technology(Ethicon K133314)
Device Description:	The Reprocessed Harmonic FOCUS Shears + Adaptive TissueTechnology is a sterile, single-patient use surgical instrumentconsisting of a soft grip scissor handle housing assembly withtwo hand controls (MIN for minimum power level and MAXfor maximum power level). The instrument's working length is9 cm in length with a 16 mm active blade length. Theinstrument allows for the cutting and coagulation of vessels upto and including 5 mm in diameter.
Model Numbers	HAR9FR
Indications For Use:	The Reprocessed Harmonic FOCUS Shears + Adaptive TissueTechnology are indicated for soft tissue incisions whenbleeding control and minimal thermal injury are desired. Theinstrument can be used as an adjunct to or substitute forelectrosurgery, lasers, and steel scalpels in general,otorhinolaryngologic (ENT), plastic, pediatric, gynecologic,urologic. exposure to orthopedic structures (such as spine andjoint space) and other open procedures.
TechnologicalCharacteristics:	The Reprocessed Harmonic FOCUS Shears + Adaptive TissueTechnology use an EEPROM memory chip that stores deviceidentification, usage track ing, and operating parameters for useby the Generator G 11 that provides power for the HarmonicFOCUS Shears + Adaptive Tissue Technology. AdaptiveTissue Technology refers to the power output algorithm that isutilized by the devices. During use, the Adaptive TissueTechnology algorithm parameters stored on the deviceEEPROM are read by the generator and used to reduce thepower (current) to the instrument and provide a secondary,higher pitched generator activation tone as Adaptive TissueTechnology regulates the delivery of energy. To do this thegenerator monitors the thermal condition of the blade duringdevice activation.
Functional and SafetyTesting:	Reprocessed devices were tested to demonstrate appropriatefunctional characteristics. Process validation testing wasperformed to validate cleaning and sterilization as well asdevice packaging. In addition, the manufacturing processincludes visual and validated functional testing of all productsproduced. The Reprocessed Harmonic FOCUS Shears +Adaptive Tissue Technology, are reprocessed no more thanone (1) time. The torque wrench accessories are reprocessedno more than two (2) times. Each device and accessory aremarked and tracked through the reprocessing cycle. After thedevice or torque wrench has reached the maximum number ofreprocessing cycles, one and two, respectively, it is rejectedfrom further reprocessing.
Summary ofNon-Clinical TestsConducted:	Specific non-clinical tests performed included: cleaningvalidation, sterilization verification, ethylene oxide residualtesting (ISO 10993-7), packaging validation (ASTM D4169,ASTM F88, ASTM F2096), and shelf-life validation (ASTM1980-07). In addition, validation of functional performance(bench testing) was performed through simulated use, visualinspection, and fatigue testing. Performance testingconducted:● Grasping Force● Artery Seal Burst and Tissue Adhesion● Vein Seal Burst and Tissue Adhesion● Electrical and Thermal Safety IEC 60601● Tissue (Jaw) Pad Life● Tissue (Jaw) Pad Removal Force● Thermal Spread and Transection TimePerformance testing shows the Harmonic FOCUSShears + Adaptive Tissue Technology performs asoriginally intended.
	In addition, the device was tested for biocompatibilityper ISO 10993-1 for external communicating device, incontact with tissue/bone/dentin and the duration ofcontact is limited exposure (<24 hours).Biocompatibility testing included:• Cytotoxicity• Sensitization• Irritation/Intracutaneous Reactivity• Acute Systemic Toxicity• Pyrogenicity
Conclusion:	Sterilmed conducted performance testing for the ReprocessedHarmonic FOCUS Shears + Adaptive Tissue Technologyagainst the OEM predicate device, Ethicon Harmonic FOCUSShears + Adaptive Tissue Technology (K133314). Resultsdemonstrated substantial equivalence to the predicate deviceswith respect to safety and effectiveness.Sterilmed therefore concludes that the Reprocessed HarmonicFOCUS Shears + Adaptive Tissue Technology is safe,effective, and substantially equivalent to the predicate device,Ethicon Harmonic FOCUS Shears + Adaptive TissueTechnology.

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Model Number included in submission K190610:

MODEL	DESCRIPTION
HAR9FR	Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology

Regulation Number and Section

N/A

Reprocessed Single-Use Device Models Subject to Clearance:

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *

Reprocessed Single-Use Device Models Subject to Clearance:

510(K) SUMMARY

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!