(49 days)
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.
Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are a sterile, single patient use 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 has a curved blade and clamp arm with Teflon pad. The instrument is 9 cm in length with a 16 mm active blade length. The Reprocessed HARMONIC FOCUS®+ Shears instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. Each Reprocessed HARMONIC FOCUS®+ Shears instrument is packaged with one sterile, single patient use, disposable Torque Wrench.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the de novo effectiveness of a novel device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/ML or diagnostic devices with quantifiable performance metrics (like sensitivity, specificity, AUC) is not directly applicable in the same way.
However, we can interpret acceptance criteria in the context of this 510(k) as demonstrating that the reprocessed device performs as well as the original predicate device, and that the reprocessing itself does not introduce new safety or effectiveness concerns.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided document for each specific point:
Acceptance Criteria and Study for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
In the context of this 510(k) submission for a reprocessed device, the "acceptance criteria" are implicitly tied to demonstrating that the reprocessed device is substantially equivalent to the original predicate device and that the reprocessing process does not compromise safety or effectiveness. The "study" refers to the performance data submitted to the FDA to support this claim.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a reprocessed device, the acceptance criteria are not explicitly defined as numerical thresholds for specific performance metrics like those for a diagnostic AI. Instead, they are comparative, aiming to show that the reprocessed device performs equivalently to the new, original device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device | "The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended." This generally means that the reprocessed device should not introduce new safety risks and should achieve the same clinical outcomes as the original device. Specific tests contributing to this include: - Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. - Electromagnetic Compatibility: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. - Functional Performance (Comparative): Evaluation of ability to seal and divide vessels up to 5mm, including: - Thermal spread - Transection time - Burst pressure - Device functionality - Device reliability - Preclinical Laboratory Evaluations (Animal Model): Acute and chronic survival studies to evaluate thermal spread and ability to achieve hemostasis. |
| Biocompatibility | Testing was conducted. (Assumed acceptance: demonstrates no new biocompatibility risks after reprocessing). |
| Validation of Reprocessing | Testing was conducted. (Assumed acceptance: demonstrates the reprocessing method effectively cleans, restores, and prepares the device for reuse without degradation or contamination). The description mentions "removal of adherent visible soil and decontamination." |
| Sterilization Validation | Testing was conducted. (Assumed acceptance: demonstrates the reprocessed device is sterile). |
| Packaging Validation | Testing was conducted. (Assumed acceptance: demonstrates packaging maintains sterility and device integrity). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for the "bench and laboratory testing" or the "preclinical laboratory evaluations." It mentions "animal model" but not the number of animals or trials. The data provenance is internal to the manufacturer's testing, presumably conducted at their facilities or certified labs. No indication of country of origin of data beyond where Stryker Sustainability Solutions operates (Tempe, Arizona). The studies are inherently prospective in nature, as they involve testing the reprocessed devices under controlled conditions.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the document. For a reprocessed surgical instrument, "ground truth" is not established by expert consensus on image interpretation, but rather by objective physical, chemical, and biological testing as outlined above (e.g., burst pressure measurements, bacterial counts, visual inspection criteria, etc.). There would be engineers, microbiologists, and other technical experts involved in conducting and interpreting these tests, but they are not "experts establishing ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert interpretation of data (e.g., medical images) to establish a consensus ground truth. For instrument performance testing, the results are typically quantitative measurements or pass/fail criteria based on defined specifications, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are conducted for diagnostic devices (often AI-assisted) to assess how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. This document is for a physical surgical instrument, not a diagnostic tool where human interpretation is involved.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. There is no AI algorithm being evaluated for its standalone performance in a diagnostic capacity. The "Adaptive Tissue Technology" refers to algorithms within the generator that communicate with the device to optimize energy delivery, but this is an integrated system functionality, not a standalone diagnostic algorithm. The functional performance tests implicitly evaluate the device's performance, which includes the integrated technology, without specific focus on "algorithm-only" performance as a separate entity.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Physical and Mechanical Measurements: Such as thermal spread, transection time, burst pressure, device functionality, and reliability, measured against predetermined specifications or compared to the predicate device's performance.
- Biological/Chemical Testing: Biocompatibility, sterilization validation (e.g., sterility assurance level), and validation of cleaning (e.g., residual protein levels, visual cleanliness).
- Preclinical (Animal Model) Outcomes: Evaluation of hemostasis and thermal spread in vivo.
This is distinct from "expert consensus," "pathology," or "outcomes data" in the context of diagnostic performance.
8. Sample Size for the Training Set
Not applicable. This is a reprocessed physical device, not an AI/ML algorithm that learns from a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm in this submission.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Stryker Sustainability Solutions Ms. Chelsea Cullen Sr. Regulatory Affairs Specialist 1810 W Drake Drive Tempe, Arizona 85283
Re: K170456
Trade/Device Name: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Regulatory Class: Unclassified Product Code: NLQ Dated: February 13, 2017 Received: February 15, 2017
Dear Ms. Cullen:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
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" (21 CFR 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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Models Subject to Clearance:
| ModelNumber | Device Name/Description | Device Length | Active BladeLength |
|---|---|---|---|
| HAR9F | HARMONIC FOCUS® Shears + AdaptiveTissue Technology | 9cm | 16mm |
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology
Indications for Use (Describe)
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.
| 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.
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K170456
SECTION 5: 510(k) SUMMARY
Submitter:
Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283
Contact:
Chelsea Cullen Sr. Regulatory Affairs Specialist 888-888-3433x5506 (o) 480-763-5310 (f) chelsea.cullen@stryker.com
Date of Preparation: February 13, 2017
Name of Device:
| Trade/Proprietary Name: | Reprocessed HARMONIC FOCUS® Shears + AdaptiveTissue Technology |
|---|---|
| Model Number: | HAR9F |
| Common Name: | Scalpel, Ultrasonic, Reprocessed |
| Classification Information: | Class: UnclassifiedUnclassified Reason: Pre-AmendmentProduct Code: NLQ |
Predicate Devices:
| ModelNumber | 510(k)Number | 510(k) Title | OriginalManufacturer |
|---|---|---|---|
| HAR9F | K133314 | HARMONIC FOCUS® Shears + Adaptive TissueTechnology | Ethicon Endo-Surgery |
Device Description:
Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are a sterile, single patient use 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 has a curved blade and clamp arm with Teflon pad. The instrument is 9 cm in length with a 16 mm active blade length. The Reprocessed HARMONIC FOCUS®+ Shears instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.
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Each Reprocessed HARMONIC FOCUS®+ Shears instrument is packaged with one sterile, single patient use, disposable Torque Wrench.
Intended Use:
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, otorhinolarynqologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Summary of Technological Characteristics:
The Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology use an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC FOCUS Shears + Adaptive Tissue Technology. Adaptive Tissue Technology refers to the advanced algorithms that allow the generator to communicate with the device and properly respond to the changing tissue conditions. The design, materials, and intended use of the reprocessed device 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 sizes is utilized. The differences between the predicate device and the reprocessed device include a replacement Torque Wrench and replacement tissue pad. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of the HARMONIC FOCUS® Shears + Adaptive Tissue Technology 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.
Performance Data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology. This included the following tests:
- Biocompatibility
- . Validation of Reprocessing
- . Sterilization Validation
- Functional Performance Tests ●
- Electrical Safety Testing
- Electromagnetic Compatibility Testing
- . Packaging Validation
The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. 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
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to 5mm, including: thermal spread, transection time, burst pressure, device functionality, and device reliability.
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 the reprocessed device. The results of the evaluations demonstrate that the Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology effectively cut and coagulated vessels 1 to 5mm in diameter.
The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.
Conclusion:
The results of bench testing and preclinical laboratory evaluations demonstrate that the Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are at least as safe and effective and perform as well as the identified leqally marketed predicate device as described herein.
N/A