The Reprocessed HARMONIC 1100 Shears 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, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

Device Description

The Reprocessed HARMONIC 1100 Shears instrument is a sterile, single patient used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. It consists of an ergonomic handle with an integrated hand piece and two energy delivery buttons. 1) Energy button for power levels 1-5, and 2) Energy with Advanced Hemostasis button for large vessel sealing. The instrument is available in two shaft lengths (20 cm and 36 cm). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instrument has a clamp and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The instrument are intended to represent relative vessel size. The Energy button is in diameter. When the Energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis is reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The HARMONC 1100 Shears instrument is designed for use exclusively with the Generator 11 (GEN11) software version 2018-1 or later.

AI/ML Overview

The provided text is a 510(k) summary for reprocessed HARMONIC 1100 Shears. It describes the device, its intended use, and a study comparing it to predicate devices. However, it does not contain detailed information about specific acceptance criteria or the study design and results in a format that allows for the extraction of all the requested information.

Here's an analysis of what can be extracted and what is missing:

The submission is for Stryker Sustainability Solutions' Reprocessed HARMONIC 1100 Shears (HAR1120 and HAR1136). The focus of the provided document is the expansion of the indications for use to include coagulation of veins up to and including 7 mm in diameter.

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

The document states: "Supplemental chronic 21-day survival studies were completed to assess the long-term seal quality of veins up to and including 7 mm in diameter. The data supports the expansion of the include coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis."
Missing from the text: Specific quantitative acceptance criteria (e.g., minimum seal burst pressure, failure rates) and the precise reported device performance metrics against those criteria are not detailed. The phrase "long-term seal quality" is qualitative without acceptance thresholds.

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

The study is described as "Supplemental chronic 21-day survival studies." This implies a prospective animal study.
Missing from the text: The number of animals or vessels tested (sample size) for this study is not provided. The country of origin for the data is also not specified, though it's implied to be a pre-clinical study.

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 question is not applicable to this type of device and study. The "ground truth" for vessel sealing devices in pre-clinical studies is typically based on physiological measurements (e.g., burst pressure, histological analysis) rather than expert interpretation of images. The study involved "animal study data," which suggests direct observation and measurement in live subjects.

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

Not applicable. As noted above, this study is not interpreting images or clinical outcomes that would require an adjudication method by human readers. It's a technical performance study.

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 document describes a medical device (surgical shears), not an AI-based diagnostic or assistive technology for human readers.

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

Not applicable. This document describes a medical device, not an algorithm.

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

The ground truth in this context would be the directly measured "long-term seal quality of veins" in the animal model. This would likely involve physiological parameters like burst pressure, histological examination of the sealed vessels for integrity, and potentially observation of complications over the 21-day survival period.
Missing from the text: The specific metrics and methods used to define "long-term seal quality" are not detailed.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary of available information regarding the device's performance study:

Device: Reprocessed HARMONIC 1100 Shears (HAR1120, HAR1136)

Purpose of Study: To support the expansion of indications for use to include coagulation of veins up to and including 7 mm in diameter.

Study Type: Supplemental chronic 21-day survival studies in an animal model.

Evaluation Focus: Assessment of "long-term seal quality" of veins up to and including 7 mm in diameter.

Conclusion stated: "The data supports the expansion of the include coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis."

Missing Critical Information from the provided text:

Detailed quantitative acceptance criteria.
Specific numerical results of the "long-term seal quality" assessment.
The exact sample size (number of animals or vessels) used in the study.
Specific ground truth metrics (e.g., burst pressure values, histological findings).
Details of the study protocol.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

July 3, 2024

Stryker Sustainability Solutions Scott English scott.english(@stryker.com 1810 West Drake Drive Tempe, Arizona 85283

Re: K241606

Trade/Device Name: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) Regulatory Class: Unclassified Product Code: NLO, LFL Dated: June 4, 2024 Received: June 4, 2024

Dear Scott English:

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/cdrb/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.

{1}------------------------------------------------

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 (OS) 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 820.70) 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 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-reportingcombination-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.

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-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.

Digitally signed by Long H. Chen Long H. Chen-S ; Date: 2024.07.03 16:05:30 -04'00'

Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices

{2}------------------------------------------------

OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Reprocessed Single-Use Device Models Subject to Clearance:

OEM	ModelNumber	DeviceName/Description	ShaftDiameter	Shaft Length
Ethicon	HAR1120	HARMONIC 1100Shears	5 mm	20 cm
Ethicon	HAR1136	HARMONIC 1100Shears	5 mm	36 cm

{4}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241606

Device Name

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)

Indications for Use (Describe)

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

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."

{5}------------------------------------------------


	510(k) Summary	Prepared on: 2024-06-04
Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Stryker Sustainability Solutions
Applicant Address	1810 West Drake Drive Tempe AZ 85283 United States
Applicant Contact Telephone	9014511456
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 1100 Shears, 5mm Diameter, 20cm Length(HAR1120);Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length(HAR1136)
Common Name	Reprocessed HARMONIC 1100 Shears
Classification Name	Single-Use Reprocessed Ultrasonic Surgical Instruments
Regulation Number	N/A
Product Code(s)	NLQ
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K233471	Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm	NLQ
K200841	Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length	LFL

Device Description Summary

21 CFR 807.92(a)(4)

Energy button for power levels 1-5, and
Energy with Advanced Hemostasis button for large vessel sealing.

The instrument is available in two shaft lengths (20 cm and 36 cm). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instrument has a clamp and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The instrument are intended to represent relative vessel size. The Energy button is indiameter. When the Energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis is reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The HARMONC 1100 Shears instrument is designed for use exclusively with the Generator 11 (GEN11) software version

{6}------------------------------------------------

K241606

Page 2/2

2018-1 or later.

Intended Use/Indications for Use

The Reprocessed HARMONC 1100 Shears 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 electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

Indications for Use Comparison

The difference in indications for use does not constitute a new intended use. The predicate indications for use were limited to coagulation of vessels, up to 5 mm in diameter for veins and up to 7 mm in diameter for arteries, using the Energy button with Advanced Hemostasis. The subject device is indicated for for coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis. The inclusion of veins up to and including 7 mm in diameter is supported by additional chronic animal study data per the recommendation of FDA reviewers of K233471.

Technological Comparison

There are no differences in the technological characteristics (i.e., design, material, chemical composition, principal of operation, energy source, etc.) The subject device is the same device as the predicate. The expansion of the indications for use.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Supplemental chronic 21-day survival studies were completed to assess the long-term seal quality of veins up to and including 7 mm in diameter. The data supports the expansion of the include coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

Regulation Number and Section

N/A