(245 days)
Not Found
No
The summary explicitly states "without Adaptive Tissue Technology" and there are no mentions of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is used for soft tissue incisions and other surgical procedures, which are therapeutic interventions.
No
The device description and intended use indicate that the device is a surgical instrument used for cutting and coagulation of soft tissue, not for diagnosis.
No
The device is a reprocessed surgical instrument (Harmonic ACE+ Shears), which is a physical hardware device, not software. The summary describes physical testing and reprocessing procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use of the Medline ReNewal Reprocessed Harmonic ACE+ Shears clearly indicate that they are surgical instruments used for cutting and coagulating soft tissue during surgical procedures performed on the body. They are used for making incisions and controlling bleeding.
The information provided describes a surgical tool, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
Medline ReNewal 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, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
NLO
Device Description
Medline ReNewal Reprocessed Harmonic ACE+ 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
Not Found
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)
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, seal quality and histopathology; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, 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.
K120729 Ethicon Endo-Surgery Harmonic ACE® 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.
Not Found
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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2016
Surgical Instrument Services and Savings (dba Medline Renewal) Ms. Brandi Panteleon Director, Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K151405
Trade/Device Name: Medline Renewal Reprocessed Harmonic Ace + Shears without Adaptive Tissue Technology
Regulatory Class: Unclassified Product Code: NLO Dated: December 23, 2015 Received: December 28, 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 of medical devicerelated 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/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 yours,
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
2
| Device Model | Device Name | Device Size |
|---|---|---|
| HAR23M | Medline ReNewal Reprocessed ACE+ | |
| Shears without Adaptive Tissue | ||
| Technology | 5 x 23 cm | |
| HAR36M | Medline ReNewal Reprocessed ACE+ | |
| Shears without Adaptive Tissue | ||
| Technology | 5 x 36 cm |
Reprocessed Single-Use Device Models Included in Clearance:
3
Indications for Use
510(k) Number (if known) K151405
Device Name
Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology
Indications for Use (Describe)
Medline ReNewal 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, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic 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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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the right. To the right of the Medline logo is a vertical line, followed by the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
510(k) Summary — K151405
| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Names | Brandi Panteleon
Director, QA/RA
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com |
| Date Prepared | May 20, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Harmonic ACE+ Shears
without Adaptive Tissue Technology, models HAR23M and HAR36M
Common Name: Unclassified/scalpel, ultrasonic reprocessed |
| Classification | Unclassified/scalpel ultrasonic, reprocessed
Product code: NLQ |
| Predicate
Device | K120729 Ethicon Endo-Surgery Harmonic ACE® Shears+ Adaptive Tissue
Technology |
| Device
Description | Medline ReNewal Reprocessed Harmonic ACE+ 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 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. |
| Technological
Characteristics | The technological characteristics and the fundamental scientific technology
of the subject devices are identical to the predicate device. The proposed
devices are a reprocessed version of the predicate devices. |
•
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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the right. To the right of the Medline logo is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in a smaller font below.
| | The functional characteristics of the proposed devices have been evaluated
and found to be equivalent to the predicate devices based on the following
tests: | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Performance
Testing | 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, seal quality and histopathology; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. | |
| Conclusion | Based on comparisons of the indications for use, intended use,
technological characteristics, and performance data to the predicate
devices, Medline ReNewal Reprocessed Harmonic ACE+ Shears without
Adaptive Tissue Technology are substantially equivalent to the predicate
devices. | |