(289 days)
No
The document explicitly states "without Adaptive Tissue Technology" and there are no mentions of AI, ML, or related concepts in the description or performance studies.
Yes.
The device is used for soft-tissue incisions and for bleeding control during various surgical procedures, which are therapeutic interventions.
No
Explanation: The device is a surgical tool used for soft-tissue incisions and bleeding control, not for diagnosing medical conditions. The "Intended Use" section clearly states its function as a surgical instrument.
No
The device description clearly indicates it is a physical surgical instrument (shears) that is reprocessed, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for soft-tissue incisions during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is described as a surgical instrument (shears) used for cutting and coagulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing samples outside the body. This device is clearly intended for use within the body during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft-tissue incisions, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatic, gynecologic, urologic, orthopedic structures (such as spine and joint space)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K133314 - Ethicon Endo-Surgery Harmonic FOCUS Shears + Adaptive Tissue Technology
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K124033 – MEDISISS Reprocessed Ultrasonic Instrument, K100597 - Ethicon Endo-Surgery Harmonic FOCUS Shears
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
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
2
Device Models Subject to Clearance:
| Model Number | Device Description | Device Length | Active Blade Length |
|---|---|---|---|
| HAR9FM | Medline ReNewal Reprocessed | ||
| Harmonic FOCUS+ Shears without | |||
| Adaptive Tissue Technology | 9 cm | 16 mm |
3
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
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 ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Names | Brandi Panteleon
Director, Regulatory Affairs
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com |
| Date Prepared | May 5, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Harmonic FOCUS+ Shears without
Adaptive Tissue Technology
Common Name: scalpel, ultrasonic, reprocessed |
| Classification | Unclassified/Scalpel, Ultrasonic, Reprocessed
Product Code: NLQ |
| Predicate
Device | K133314 - Ethicon Endo-Surgery Harmonic FOCUS Shears + Adaptive
Tissue Technology |
| Reference
Devices | K124033 – MEDISISS Reprocessed Ultrasonic Instrument
K100597 - Ethicon Endo-Surgery Harmonic FOCUS Shears |
| Device
Description | 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. |
| Intended Use | 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,
pediatric, gynecologic, urologic, exposure to orthopedic structures (such as
spine and joint space) and other open procedures. |
5
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:
| Technological
| Characteristics | 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. |
|---|---|
| Performance | |
| Testing | 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. |