(289 days)
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology is 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, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology. The focus of the acceptance criteria and study is on demonstrating substantial equivalence to a predicate device, rather than on a new AI/algorithm-driven device with standalone performance or human-in-the-loop studies.
Therefore, the requested information on AI-specific criteria (like effect size of AI assistance, standalone algorithm performance, training set details, and expert adjudication methods for a test set based on expert ground truth) is not applicable to this document. This document describes the testing for substantial equivalence of a reprocessed surgical instrument.
Here's the information that can be extracted from the provided text, tailored to the context of a reprocessed medical device:
Acceptance Criteria and Device Performance (for a Reprocessed Surgical Instrument)
The study focuses on demonstrating substantial equivalence of the reprocessed device to the predicate device. The acceptance criteria are implicit in the performance testing conducted to show that the reprocessed device maintains the functional characteristics and safety profile of the original device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Functional Performance | Simulated Use | Evaluated and found to be substantially equivalent to the predicate device (implies meeting intended functional parameters) |
| Grasping/Pulling Force | Evaluated and found to be substantially equivalent to the predicate device | |
| Cutting Effectiveness/Functionality | Evaluated and found to be substantially equivalent to the predicate device | |
| Drop Test | Evaluated and found to be substantially equivalent to the predicate device | |
| Device Integrity | Evaluated and found to be substantially equivalent to the predicate device | |
| Cutting/Coagulation Evaluation for a Prolonged Period of Time | Evaluated and found to be substantially equivalent to the predicate device | |
| Thermal Analysis Characterization | Evaluated and found to be substantially equivalent to the predicate device | |
| Tissue Sticking | Evaluated and found to be substantially equivalent to the predicate device | |
| Vessel Burst Pressure | Evaluated and found to be substantially equivalent to the predicate device | |
| Safety & Biocompatibility | Electrical Safety (in accordance with IEC 60601-1) | Evaluated and found to be substantially equivalent to the predicate device |
| Cleaning (Protein, Carbohydrates, Hemoglobin, and Endotoxins) | Evaluated and found to be substantially equivalent to the predicate device (implies residual levels within acceptable limits) | |
| Biocompatibility (Sensitization, Irritation, and Acute Systemic Toxicity) | Evaluated and found to be substantially equivalent to the predicate device (implies no unacceptable biological reactions) | |
| Sterility & Stability | Performance Qualification | Evaluated and found to be substantially equivalent to the predicate device |
| Sterilization Validation | Evaluated and found to be substantially equivalent to the predicate device (implies maintaining sterility assurance level) | |
| Product Stability | Evaluated and found to be substantially equivalent to the predicate device | |
| Overall Conclusion | The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device. Based on the information provided, the Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology are substantially equivalent to the predicate device. | The conclusion states that the device meets the criteria for substantial equivalence to the predicate device based on the comprehensive testing performed across functional, safety, and operational aspects. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test performed (e.g., number of reprocessed devices tested for "simulated use" or "tissue sticking"). The nature of these tests for a physical device would involve a defined number of units or test cycles, but these numerical details are not provided in the summary.
Data Provenance: The data provenance is from the manufacturer (Medline ReNewal) and is part of their submission to the FDA for a 510(k) premarket notification. It is derived from testing conducted specifically for this reprocessed device to demonstrate its equivalence. The document does not specify the country of origin of the data or explicitly state whether it's retrospective or prospective, but testing for a 510(k) submission is typically prospective for the purpose of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. This is a submission for a reprocessed physical medical device, not an AI/software device that relies on expert interpretation to establish ground truth for a test set. The "ground truth" for this device would be its physical and functional specifications and performance against established standards and the predicate device, demonstrated through objective tests.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods like 2+1 or 3+1 are used when human interpretation of data (e.g., images for a diagnostic AI) is ambiguous and requires expert consensus to establish a definitive ground truth. For a physical device undergoing performance testing, the results are typically quantitative or directly observable and do not require this type of expert adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes a reprocessed surgical instrument, which does not involve human readers interpreting cases with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical surgical instrument. The concept of "standalone algorithm performance" does not apply. The device's performance is inherently "standalone" in that it performs its physical function.
7. The Type of Ground Truth Used
The "ground truth" for this reprocessed device is established through:
- Predicate Device Specifications and Performance: The original manufacturer's specifications and the known performance characteristics of the legally marketed predicate devices (K133314, K124033, K100597) serve as the benchmark.
- Industry Standards: Compliance with relevant industry standards, such as IEC 60601-1 for electrical safety.
- Objective Performance Metrics: Direct measurement of physical and functional characteristics (e.g., grasping force, cutting effectiveness, residual levels after cleaning, sterility validation).
- Biocompatibility Testing: Ensuring that the reprocessed device does not pose new or increased biological risks.
8. The Sample Size for the Training Set
Not Applicable. This document describes a reprocessed physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Surgical Instrument Service and Savings (dba Medline ReNewal) Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 Southwest 6th Street December 16, 2015 Redmond, Oregon 97756
Re: K150524
Trade/Device Name: Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology Regulatory Class: Unclassified
Product Code: NLQ Dated: December 4, 2015 Received: December 7, 2015
Dear Ms. Panteleon:
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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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/Resourcesfor You/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 vours. Joshua C. Mipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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:
| Model Number | Device Description | Device Length | Active Blade Length |
|---|---|---|---|
| HAR9FM | Medline ReNewal ReprocessedHarmonic FOCUS+ Shears withoutAdaptive Tissue Technology | 9 cm | 16 mm |
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Indications for Use
510(k) Number (if known) K150524
Device Name
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
Indications for Use (Describe)
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology is indicated for softtissue 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, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image contains the Medline Renewal logo. The word "MEDLINE" is in blue and to the left of a blue star-like symbol. To the right of the Medline logo is the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
K150524/S001 Traditional 510(k) Notification Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
(replacement page 25 of 88)
5.0 510(k) Summary
| Submitter/Owner | Medline ReNewal2747 SW 6th St.Redmond, OR 97756 |
|---|---|
| Contact Names | Brandi PanteleonDirector, Regulatory AffairsP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.com |
| Date Prepared | May 5, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Harmonic FOCUS+ Shears withoutAdaptive Tissue TechnologyCommon Name: scalpel, ultrasonic, reprocessed |
| Classification | Unclassified/Scalpel, Ultrasonic, ReprocessedProduct Code: NLQ |
| PredicateDevice | K133314 - Ethicon Endo-Surgery Harmonic FOCUS Shears + AdaptiveTissue Technology |
| ReferenceDevices | K124033 – MEDISISS Reprocessed Ultrasonic InstrumentK100597 - Ethicon Endo-Surgery Harmonic FOCUS Shears |
| DeviceDescription | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears withoutAdaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, andsterilized for an additional clinical use. |
| Intended Use | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears withoutAdaptive Tissue Technology is indicated for soft-tissue incisions whenbleeding control and minimal thermal injury are desired. The instrument canbe used as an adjunct to, or substitute for, electrosurgery, lasers, and steelscalpels in general, otorhinolaryngolic (ear, nose and throat [ENT]), plastic,pediatric, gynecologic, urologic, exposure to orthopedic structures (such asspine and joint space) and other open procedures. |
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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "MEDLINE" is in blue and to the left of a blue star shape. To the right of the Medline logo is the word "Renewal" in green and blue. Underneath "Renewal" is the phrase "Full Circle Reprocessing" in blue.
K150524/S001 Traditional 510(k) Notification Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
(replacement page 26 of 88)
The technological characteristics and the fundamental scientific technology of the subject device are identical to the predicate and reference devices:
| TechnologicalCharacteristics | K133314 - Ethicon Endo-Surgery Harmonic FOCUS Shears + Adaptive Tissue Technology; used as the primary predicate to support intended use, technological characteristics, and functional performance specifications; K124033 - MEDISISS Reprocessed Ultrasonic Instrument; used as a reference predicate to support cleaning, biocompatibility, and product stability of the reprocessed device, and K100597 - Ethicon Endo-Surgery Harmonic FOCUS Shears; used as a reference predicate to identify design progression of the original device. |
|---|---|
| PerformanceTesting | The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests: simulated use; grasping/pulling force; cutting effectiveness/functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking; vessel burst pressure; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, hemoglobin, and endotoxins; biocompatibility; sensitization, irritation, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. |
| Conclusion | Based on the information provided, the Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology are substantially equivalent to the predicate device. |
N/A