(118 days)
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, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of veins up to and including 5 mm in diameter and arteries up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
The Reprocessed HARMONIC 1100 Shears sterile instruments are used for dissection, grasping, coaqulation, and cutting between the blade and clamp arm. Each device model consists of an ergonomic handle, an integrated hand piece, and two energy delivery buttons:
- Energy Button - User can adjust power levels from 1-5
- Energy button with Advanced Hemostasis – For larger vessel sealing; user cannot adjust.
The instruments are available in two shaft lengths, 20 cm and 36 cm. An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument has a clamp arm and coated curved blade that are deigned to work through a 5 mm trocar, through a 5mm 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 two dashes on the instrument are intended to represent relative vessel size. The energy button is indicated for vessels up to 5 mm 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 in used, cutting speed in 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.
This document is a 510(k) premarket notification decision letter from the FDA regarding the Reprocessed HARMONIC 1100 Shears. It states that the device is substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not involve an AI/ML component, and therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML devices is not applicable to this document. The document describes physical and performance tests for a reprocessed surgical instrument, not an AI-powered diagnostic or therapeutic device.
Therefore, I cannot provide the information requested in your prompt based on the provided text.
{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.
February 20, 2024
Stryker Sustainability Solutions Aphrodeja Crutch Staff Specialist, Regulatory Affairs 1810 Drake Dr. Tempe, Arizona 85283
Re: K233471
Trade/Device Name: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) Regulation Number: 21 CFR Unclassified Regulation Name: Regulatory Class: Class II Product Code: NLQ Dated: October 23, 2023 Received: October 25, 2023
Dear Aphrodeja Crutch:
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.
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"
{1}------------------------------------------------
(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 OS 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 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 Mark Mark Trumbore -S Trumbore -S Date: 2024.02.20 14:09:02 -05'00' Mark Trumbore, 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
{2}------------------------------------------------
Enclosure:
Models For This Submission
Description: Reprocessed HARMONIC 1100 Shears Model Numbers: HAR1120 and HAR1136
Physical Description/Specifications
The Reprocessed HARMONIC 1100 Shears sterile instruments are used for dissection, grasping, coaqulation, and cutting between the blade and clamp arm. Each device model consists of an ergonomic handle, an integrated hand piece, and two energy delivery buttons:
- Energy Button - User can adjust power levels from 1-5
- . Energy button with Advanced Hemostasis – For larger vessel sealing; user cannot adjust.
The instruments are available in two shaft lengths, 20 cm and 36 cm. An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument has a clamp arm and coated curved blade that are deigned to work through a 5 mm trocar, through a 5mm 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 two dashes on the instrument are intended to represent relative vessel size. The energy button is indicated for vessels up to 5 mm 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 in used, cutting speed in 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.
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K233471
Device Name
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
Indications for Use (Describe)
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, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of veins up to and including 5 mm in diameter and arteries up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
| 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."
{4}------------------------------------------------
510(k) Summary
| Applicant Name: | Stryker Sustainability Solutions |
|---|---|
| Contact Person: | Aphrodeja CrutchStaff Specialist1810 Drake DriveTempe, AZ 85283Phone: 404-993-1981Email: Aphrodeja.Crutch@stryker.com |
| Device Trade Name: | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cmLength (HAR1120); Reprocessed HARMONIC 1100 Shears,5mm Diameter, 36cm Length (HAR1136) |
| Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | Instrument, Ultrasonic Surgical |
| Regulation Number: | Unclassified |
| Product Code: | NLO |
| Device Class: | Class II |
| Date Prepared: | 02/20/2024 |
| Predicate Device: | HARMONIC 1100 Shears 20cm Length; HARMONIC 1100Shears 36cm Length (K200841) |
| Predicate Product Code: | LFL |
| Description | The Reprocessed HARMONIC 1100 Shears instrument is asterile, single patient use instrument used for dissection,grasping, coagulation, and cutting between the blade andclamp arm. It consists of an ergonomic handle with anintegrated hand piece and two energy delivery buttons.1) Energy button for power levels 1-5, and2) Energy with Advanced Hemostasis button for large vesselsealing.The instrument is available in two shaft lengths (20 cm and 36cm). An integrated audible and tactile mechanism in the griphousing indicates full trigger closure. The instrument has aclamp arm and coated curved blade that are designed to work |
| through a 5 mm trocar, through a 5 mm reducer cap in alarger diameter trocar, or through an incision without the useof a trocar. The instrument shafts can be rotated continuouslyto facilitate visualization and access to targeted tissue. Thetwo dashes on the instrument are intended to representrelative vessel size. The Energy button is indicated for vesselsup to 5mm in diameter. When the Energy button is used,cutting speed is the fastest. The energy button with AdvancedHemostasis is designed for larger vessels and is indicated forveins up to and including 5 mm in diameter and arteries up toand including 7 mm in diameter. When the Energy buttonwith Advanced Hemostasis is used, cutting speed is reducedand hemostasis is maximized. The instrument utilizesAdaptive Tissue Technology. This provides the generator withthe ability to identify and monitor the instrument during use,which enables the generator to modulate and adjust its poweroutput as well as provide audible feedback to the user asappropriate. The HARMONIC 1100 Shears instrument isdesigned for use exclusively with the Generator 11 (GEN11)software version 2018-1 or later. | |
| Indications for Use: | The Reprocessed HARMONIC 1100 Shears are indicated forsoft tissue incisions when bleeding control and minimalthermal injury are desired. The instruments can be used as anadjunct to or substitute for electrosurgery, lasers and steelscalpels in general, pediatric, gynecologic, urologic, thoracic,sealing and transection of lymphatic vessels, and other openand endoscopic procedures. The instruments allow for thecoagulation of veins up to and including 5 mm in diameterand arteries up to and including 7 mm in diameter, using theEnergy button with Advanced Hemostasis. |
| Summary of Intended Use andTechnologies: | The design, materials, and intended use of the ReprocessedHARMONIC 1100 Shears are equivalent to the predicatedevice. The mechanism of action of the reprocessed device isidentical to the predicate device in that the same standardmechanical design, materials, and size is utilized. There are nochanges to the claims, intended use, clinical application,patient population, performance specifications, or method ofoperation. In addition, Stryker Sustainability Solutions'reprocessing of the device includes removal of adherentvisible soil and decontamination. Each individual device istested for appropriate function of its components prior topackaging and labeling operations. The only differencesbetween the Reprocessed HARMONIC 1100 Shears and thepredicate HARMONIC 1100 Shears are that the device isreprocessed, and some device components are replaced withequivalent components during the reprocessing operation. |
| Non-Clinical Testing: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of the ReprocessedHARMONIC 1100 Shears. This included the following tests: |
| • Biocompatibility• Validation of Reprocessing• Sterilization• Electrical Safety and Electromagnetic Compatibility• Functional Performance TestsBlade to Clamp Arm AngleActuating Trigger ForceEnergy Button Activation ForceAdvanced Hemostasis (AH) Button Activation ForceRotation Knob ForceJaw Clamp ForceTissue Retention ForceLeak TestBend TestATT Functionality and Transection TimeBurst PressureMaximum Jaw and Shaft TemperatureReliability CyclingBurst Pressure (Post-Reliability)Maximum Jaw and Shaft Temperature (Post-Reliability)Performance Attribute Testing | |
| The functional performance testing involved electrical safetyand electromagnetic compatibility testing in accordance withIEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, andverification/comparative testing (to the predicate device). | |
| Additionally, preclinical laboratory evaluations in an animalmodel were performed, which included acute and chronicsurvival studies. The studies were done to evaluate thermalspread and the ability to achieve hemostasis of vessels of thereprocessed device. | |
| Clinical Testing: | Clinical testing was not required for this submission. |
| Conclusion: | The subject device Reprocessed HARMONIC 1100 Shears,5mm Diameter, 20cm Length (HAR1120); ReprocessedHARMONIC 1100 Shears, 5mm Diameter, 36 cm Length(HAR1136) is substantially equivalent to the previouslycleared predicate device HARMONIC 1100 Shears 20cmLength; HARMONIC 1100 Shears 36cm Length (K200841). |
{5}------------------------------------------------
{6}------------------------------------------------
N/A