(153 days)
Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology 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, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology are sterile, single patient use instruments consisting of an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm 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 360° to facilitate visualization and access to targeted tissue. The instruments allow for the coagulation of vessels up to and including 5 mm in diameter. Each instrument is shipped with one sterile, single-use, disposable torque wrench. HARMONIC ACE® Shears without Adaptive Tissue Technology are designed for use exclusively with the Generator G11 (GEN 11) software version X or later. The scope of this Traditional 510(k) only includes the reprocessed Ethicon Harmonic Shears and not the generator.
The provided document, K133672, describes a 510(k) premarket notification for Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology. The document details the device's indications for use, technological characteristics, and performance data. The core of the submission is to demonstrate substantial equivalence to predicate devices, particularly in performance after reprocessing.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative, tabular format with specific thresholds. Instead, it describes performance through a general statement of equivalency to the predicate device and lists types of tests conducted. The implied acceptance criterion is that the reprocessed device performs "as originally intended" and is "as safe and effective as the predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (meet standards for patient safety) | Bench and laboratory testing was conducted to demonstrate biocompatibility. (Specific results or standards met are not detailed, but the FDA's clearance implies acceptance.) |
| Validation of Reprocessing (ensure effective cleaning and sterilization) | Validation of reprocessing was conducted. (Specific methods or quantitative outcomes are not detailed, but deemed sufficient for FDA clearance.) |
| Sterilization Validation (ensure sterility) | Sterilization Validation was conducted. (Specific methods or quantitative outcomes are not detailed, but deemed sufficient for FDA clearance.) |
| Functionality (cutting, coagulating, vessel sealing) | "Function test(s)" were conducted. "Performance testing demonstrates that Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology perform as originally intended for cutting and coagulating soft tissue and sealing vessels up to 5mm in diameter." This statement indicates the reprocessed device matches the functional performance of the original device in these key areas. |
| Packaging Validation (maintain sterility and integrity) | Packaging Validation was conducted. (Specific methods or quantitative outcomes are not detailed, but deemed sufficient for FDA clearance.) |
| Overall Safety and Effectiveness (equivalent to predicate) | "Stryker Sustainability Solutions concludes that the reprocessed devices are as safe and effective as the predicate devices as described herein." The FDA's 510(k) clearance implies agreement with this conclusion, indicating that the performed tests were sufficient to demonstrate substantial equivalence to the predicate devices (HARMONIC ACE® Shears + Adaptive Tissue Technology (K120729) and Harmonic Scalpel Blades and Shears, Models ACE36E and ACE23E (K060245)). |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for performance testing (e.g., number of reprocessed shears tested for function). It only states that "Bench and laboratory testing was conducted." The provenance of this data is internal to Stryker Sustainability Solutions (presumably their labs in Tempe, Arizona) and is prospective for the purpose of this 510(k) submission, meaning the tests were performed specifically to support this application. There's no mention of country of origin for the data beyond where the company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not mention the use of external experts or a formal ground truth establishment process for the performance testing of the reprocessed device itself. The "ground truth" for this type of submission is typically the established performance characteristics of the predicate device, which the reprocessed device aims to match. The testing conducted by Stryker Sustainability Solutions would then aim to confirm that the reprocessed device's performance aligns with these known characteristics of the original device.
4. Adjudication Method for the Test Set:
Not applicable. This type of submission involves bench and laboratory testing against established device specifications, not subjective interpretation requiring expert adjudication of results.
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 a study involving human readers, AI, or diagnostic image interpretation. It concerns the reprocessing of a surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" implicitly used for this submission is the performance and functional characteristics of the original, new HARMONIC ACE® Shears (the predicate devices). The reprocessing process is validated to ensure that the reprocessed device retains these characteristics. The document states: "The mechanism of action of Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology are identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized." The tests performed (biocompatibility, reprocessing validation, sterilization, function tests, packaging validation) aim to demonstrate that the reprocessed device achieves this equivalence.
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 mentioned or implied.
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MAY 0 1 2014
Page 1 of 2
K133672
SECTION 5: 510(k) SUMMARY
Submitter:
Stryker Sustainability Solutions 1810 W Drake Drive Tempe, Arizona 85283
Contact:
Scott English Regulatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) scott.english@stryker.com
Date of preparation: 27 November 2013
Name of device: Trade/Proprietary Name: Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology Classification Name: Scalpel, Ultrasonic, Reprocessed, General & Plastic Surgerv Classification: Unclassified
Product Code: NLQ
| ModelNumbers | Primary Predicate | Secondary Predicate(s) |
|---|---|---|
| HAR36HAR23 | K120729HARMONIC ACE® Shears +Adaptive Tissue Technology(Ethicon-Endo Surgery, Inc.) | K060245Harmonic Scalpel Blades and Shears,Models ACE36E and ACE23E(Ethicon-Endo Surgery, Inc.) |
Device Description:
Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology are sterile, single patient use instruments consisting of an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level).
An intecrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm 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 360° to facilitate visualization and access to targeted tissue. The instruments allow for the coagulation of vessels up to and including 5 mm in diameter.
Each instrument is shipped with one sterile, single-use, disposable torque wrench.
HARMONIC ACE® Shears without Adaptive Tissue Technology are designed for use exclusively with the Generator G11 (GEN 11) software version X or later. The scope of this Traditional 510(k) only includes the reprocessed Ethicon Harmonic Shears and not the generator.
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Indications for Use:
Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology 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, plastic, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Technological Characteristics:
The reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology incorporate most of the same technological characteristics as that of the predicate device. The mechanism of action of Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology are identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. The only difference is that the reprocessed devices do not contain the adaptive tissue technology as marketed by the original manufacturer. In addition, Stryker Sustainability Solutions' reprocessing of HARMONIC ACE® Shears without Adaptive Tissue Technology includes removal of adherent visible soil and decontamination after original device use. Each individual HARMONIC ACE® Shears without Adaptive Tissue Technology is tested for appropriate function of its components prior to packaging and labeling operations
Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology. This included the following tests:
- . Biocompatibility
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology perform as originally intended for cutting and coagulating soft tissue and sealing vessels up to 5mm in diameter.
Conclusion:
Stryker Sustainability Solutions concludes that the reprocessed devices are as safe and effective as the predicate devices as described herein.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2014
Stryker Sustainability Solutions Mr. Scott English Regulatory Affairs Specialist 1810 West Drake Drive Tempe, Arizona 85283
Re: K133672
Trade/Device Name: Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology
Regulatory Class: Unclassified Product Code: NLO Dated: March 31, 2014 Received: April 3, 2014
Dear Mr. 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 (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 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 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. Scott English
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. Binita S. Ashar -S 2014.05.01 1-7:29:35 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Mr. Scott English
| Model Number | Device Description | Diameter | Length |
|---|---|---|---|
| HAR23 | Reprocessed Harmonic ACE Shearswithout Adaptive Tissue Technology | 5 mm | 23 cm |
| HAR36 | Reprocessed Harmonic ACE Shearswithout Adaptive Tissue Technology | 5 mm | 36 cm |
and the comments of the comments of the comments of the comments of
11.000
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K133672
Device Name: Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology
Indications For Use: Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology 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, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
Stryker Sustainability Solutions Reprocessed HARMONIC ACE Shears without Adaptive Tissue Technology Traditional 510(k)
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