The Reprocessed HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

Device Description

The reprocessed HARMONIC 700 with Advanced Hemostasis are designed for soft tissue incisions requiring bleeding control and minimal thermal injury. The instruments serve as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in various procedures, including general, pediatric, gynecologic, urologic, and thoracic surgeries, as well as in the sealing and transection of lymphatic vessels. They enable the coagulation of vessels up to 7 mm in diameter using the Advanced Hemostasis hand control button.

The instruments are available in three (3) shaft lengths: 23cm, 36cm, and 45cm lengths (HAR723, HAR736, and HAR745 respectively). Each shaft length has a diameter of 5 mm. The following features are essential to the control and performance of the device:

An actuating trigger that closes and releases the clamp arm, securing tissue against the scalpel rod.
MIN/MAX control buttons that adjust energy levels between minimum and maximum modes on the generator, enabling vessel sealing up to 5 mm.
An Advanced Hemostasis button that allows the clinician to activate an additional energy mode, enabling vessel sealing up to 7 mm.
A rotation knob to rotate the shaft 360° unless energy is being delivered.
A torque wrench, a sterile, single-use component, used to apply the correct amount of torque when attaching the Hand Piece to the device.

The instruments connect to a generator and hand piece, which are essential for the device's functionality but are outside the scope of this submission.
The hand piece is a reusable component that attaches to the device and plugs into the generator, allowing the device to interface with the generator. This component contains the transducer, which converts electrical power to ultrasonic mechanical energy.

The generator is a reusable component that generates the electrical signal. Colored light indicators on the front panel of the generator visually communicate device status information to the user.

AI/ML Overview

This document is a 510(k) premarket notification for reprocessed medical devices, not an AI medical device. Therefore, the questions related to AI device performance, such as MRMC studies, training and test sets, ground truth establishment, and expert adjudication, are not applicable to the content provided.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria from the provided text, focusing on the reprocessed medical device context.

Here's the information based on the provided FDA 510(k) letter for the Reprocessed HARMONIC 700 Shears:

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

The document describes functional performance tests conducted to demonstrate safety and effectiveness. While explicit numerical acceptance criteria values are not provided, the general categories of testing imply the criteria for performance equivalence to the predicate device. The reported performance is that the device meets these criteria and is at least as safe and effective as the predicate.

Acceptance Criteria Category	Reported Device Performance
Validation of Reprocessing	Demonstrated to be effective.
Electrical Safety and Electromagnetic Compatibility	Tested in accordance with IEC 60601-1 and IEC 60601-1-2; results deemed acceptable.
Functional Performance Tests:
Jaw Clamp Force	Tested and found acceptable for intended function.
Tissue Retention Force	Tested and found acceptable for intended function.
Burst Pressure (for vessel sealing)	Tested and found acceptable for sealing vessels up to 7mm.
Maximum Jaw and Shaft Temperature	Tested and found acceptable.
Device Reliability	Demonstrated to be reliable.
ATT Functionality and Transection Time	Tested and found acceptable for intended function.
Biocompatibility	Previously identified and cleared materials and reprocessing methods were maintained, demonstrating continued biocompatibility.
Sterilization/Shelf-Life	Validated to a 10-6 sterility assurance level (SAL) through an EO sterilization process in accordance with ISO 11135. Shelf-life not explicitly detailed but implied as validated.
Preclinical Laboratory Evaluations (Animal Model):
Thermal Spread	Tested and found acceptable.
Ability to achieve Hemostasis of Vessels	Tested and found acceptable for sealing vessels up to 7mm.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes (number of devices or tests) for each bench and laboratory test.
Data Provenance: The studies were conducted as part of the manufacturer's premarket notification submission to the FDA. They are internal validation studies performed by Stryker Sustainability Solutions. The document does not specify country of origin for the data or whether it was retrospective or prospective, but these studies for 510(k) submissions are typically prospective and specifically designed for the submission.
- For the preclinical laboratory evaluations, an "animal model" was used.

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 information is not applicable to traditional reprocessing medical device submissions. Ground truth in this context is established through engineering specifications, material science, and performance testing against established standards and predicate device performance, not expert consensus on medical images or patient outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for AI model output or image interpretation, which is not relevant for this type of device submission. Device performance is determined through standardized engineering and biological tests.

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 device is a reprocessed surgical instrument, not an AI-assisted diagnostic or therapeutic device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic imaging.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to its physical properties and functionality.

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

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

Engineering specifications and design requirements: The device must meet predefined physical, mechanical, and electrical parameters.
Performance of the original (new) predicate device: The reprocessed device must demonstrate substantial equivalence in performance to the original, legally marketed predicate device.
Established industry standards: Compliance with standards like ISO 10993-1 (Biocompatibility) and ISO 11135 (EO Sterilization) serves as a ground truth for safety aspects.
Preclinical (animal) studies: In vivo performance (e.g., thermal spread, hemostasis) in animal models serves as a proxy for clinical performance.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a reprocessed medical device. The device itself is manufactured and reprocessed, not "trained" like a machine learning model.

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

U.S. Food & Drug Administration

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.00
Silver Spring, MD 20993
www.fda.gov

August 14, 2025

Stryker Sustainability Solutions
Scott English
Principal Regulatory Affairs Specialist
1810 W Drake Drive
Tempe, Arizona 85283

Re: K250898

Trade/Device Name: Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

Regulatory Class: Unclassified
Product Code: NLQ
Dated: March 25, 2025
Received: July 25, 2025

Dear Scott English:

(NOTE: Reprocessed SUD device types require a separate attachment of the list of all models cleared in the submission. A corrected SE letter will be required if the attachment is omitted.)

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 (the 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 available 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.

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K250898 - Scott English Page 2

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

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K250898 - Scott English Page 3

devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

JAMES H. JANG -S Digitally signed by JAMES H. JANG -S Date: 2025.08.14 21:16:51 -04'00'

James Jang, Ph.D.
Acting 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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K250898 - Scott English Page 4

Reprocessed Single-Use Device Models Subject to Clearance:

OM	Model Number	Device Name/Description	Shaft Diameter	Shaft Length
Ethicon	HAR723	HARMONIC 700 Shears with Advanced Hemostasis	5mm	23cm
Ethicon	HAR736	HARMONIC 700 Shears with Advanced Hemostasis	5mm	36cm
Ethicon	HAR745	HARMONIC 700 Shears with Advanced Hemostasis	5mm	45cm

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250898

Please provide the device trade name(s).

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm);
Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm);
Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable). | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Reprocessed HARMONIC 700 Shears Page 11 of 38

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510(k)#: K250898 510(k) Summary Prepared on: 2025-08-12

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Stryker Sustainability Solutions
Applicant Address	1810 W Drake Drive Tempe AZ 85283 United States
Applicant Contact Telephone	901-451-1456
Applicant Contact	Mr. Scott English
Applicant Contact Email	scott.english@stryker.com

Device Name

21 CFR 807.92(a)(2)

Device Trade Name	Reprocessed HARMONIC 700 Shears
Common Name	Single-Use Reprocessed Ultrasonic Surgical Instruments
Classification Name	Unclassified
Regulation Number	Pre-Amendment
Product Code(s)	NLQ

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K221790	HARMONIC 700 Shears	LFL
K202554	Reprocessed HARMONIC ACE +7, 5mm Diameter Shears with Advanced Hemostasis	NLQ

Device Description Summary

21 CFR 807.92(a)(4)

An actuating trigger that closes and releases the clamp arm, securing tissue against the scalpel rod.
MIN/MAX control buttons that adjust energy levels between minimum and maximum modes on the generator, enabling vessel sealing up to 5 mm.
An Advanced Hemostasis button that allows the clinician to activate an additional energy mode, enabling vessel sealing up to 7 mm.
A rotation knob to rotate the shaft 360° unless energy is being delivered.
A torque wrench, a sterile, single-use component, used to apply the correct amount of torque when attaching the Hand Piece to the device.

The instruments connect to a generator and hand piece, which are essential for the device's functionality but are outside the scope of this submission.

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K250898

The hand piece is a reusable component that attaches to the device and plugs into the generator, allowing the device to interface with the generator. This component contains the transducer, which converts electrical power to ultrasonic mechanical energy.

The generator is a reusable component that generates the electrical signal. Colored light indicators on the front panel of the generator visually communicate device status information to the user.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use for the proposed device are the same in comparison to the predicate and reference devices.

Technological Comparison

21 CFR 807.92(a)(6)

The design, materials, and intended use of the Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis are equivalent to the predicate device. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and size is utilized. There are no changes to the claims, intended use, clinical application, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of the device includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations. The only differences between the Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis and the predicate HARMONIC 700 Shears are that the device is reprocessed, and some device components are replaced with equivalent components during the reprocessing operation.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis. This included the following tests:

Validation of Reprocessing
Electrical Safety and Electromagnetic Compatibility
Functional Performance Tests
- Jaw Clamp Force
- Tissue Retention Force
- Burst Pressure
- Maximum Jaw and Shaft Temperature
- Device Reliability
- ATT Functionality and Transection Time

Biocompatibility: There were no new patient-contacting materials or changes to the reprocessing process for the subject device, and all patient-contacting materials for the subject device were previously identified, provided, reviewed, and cleared in the reference device under K202554. The biocompatibility of the patient-contacting materials was previously tested based on ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.

Sterilization/Shelf-Life: No new changes have been made to the sterilization process or parameters; Reprocessed HARMONIC 700 Shears are sterilized to a 10-6 sterility assurance level (SAL) through an EO sterilization process in accordance with ISO 11135. There have been no new materials, either patient contacting or non-patient contacting, added to the subject device that would impact the previously validated sterilization process or parameters reported from the reference device cleared in K202554.

The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1 and IEC 60601-1-2, and verification/Comparative testing (to the predicate device). The bench testing involved evaluation of the device's performance and ability to seal and divide vessels up to 7mm, including burst pressure, maximum jaw and shaft temperature, device reliability, and ATT functionality.

Additionally, preclinical laboratory evaluations in an animal model were performed, which included acute and chronic survival studies. The studies were done to evaluate thermal spread and the ability to achieve hemostasis of vessels of the reprocessed device.

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K250898

The results of bench testing and preclinical laboratory evaluations demonstrate that the Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis are at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device as described herein.

Regulation Number and Section

N/A