(240 days)
Not Found
No
The summary describes a surgical instrument for cutting and coagulating tissue using harmonic energy. There is no mention of AI or ML in the intended use, device description, or performance studies. The tests performed are standard for surgical devices and do not suggest the presence of AI/ML.
Yes.
The device is used for soft tissue incisions, coagulation, and transection during surgical procedures to control bleeding and minimize thermal injury, which directly addresses a medical condition or aims to prevent, diagnose, or treat a disease.
No
The device is indicated for soft tissue incisions, coagulation, and mechanical transection, which are therapeutic and surgical functions, not diagnostic.
No
The device description clearly states it is a physical instrument (shears) used for surgical procedures, involving mechanical transection and energy delivery, and the performance studies include hardware-specific testing like electrical safety, device integrity, and handle operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for soft tissue incisions, coagulation, and transection during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description reinforces this by detailing its function in grasping, coagulating, and transecting tissue.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status. IVDs are designed for testing samples in vitro (in glass or in a lab).
The device is a surgical instrument used for therapeutic and procedural purposes in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Medline ReNewal Harmonic ACE+7 Shears 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, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models HARH23, HARH36, and HARH45) are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue incisions, orthopedic structures (such as spine and joint space), lymphatic vessels. Procedures can include general, plastic, pediatric, gynecologic, urologic, thoracic, and other open and endoscopic procedures.
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 proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests:
• electrical safety and electromagnetic compatibility in accordance with IEC 60601-1 and 60601-1-2;
• simulated use;
• device integrity;
• handle operation;
• shaft knob rotation;
• device recognition;
• cutting time;
• thermal analysis characterization;
• tissue sticking;
• burst pressure;
• histopathology;
• seal quality;
• Cleaning:
o protein,
o carbohydrates,
o endotoxin;
• Biocompatibility:
o cytotoxicity,
o sensitization,
o irritation,
o materials-mediated pyrogen, and
o acute systemic toxicity;
• performance qualification; and
• sterilization validation.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
August 19, 2020
Surgical Instrument Service and Savings, Inc. (dba Medline ReNewal) Gail Gassner Quality Assurance Specialist II 1500 NE Hemlock Ave Redmond, Oregon 97756
Re: K193563/S001
Trade/Device Name: Medline ReNewal Reprocessed Harmonic ACE+7 Shears Regulatory Class: Unclassified Product Code: NLQ Dated: July 20, 2020 Received: July 21, 2020
Dear Gail Gassner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
K193563
Reprocessed Single-Use Device Models Included in Submission:
| Device Model | Device Name | Original
Manufacturer |
|--------------|----------------------------------------------------------------------------|--------------------------|
| HARH23 | Harmonic ACE+7 Shears
(5-mm diameter x 23-cm long shaft, 360° rotation) | Ethicon |
| HARH36 | Harmonic ACE+7 Shears
(5-mm diameter x 36-cm long shaft, 360° rotation) | Ethicon |
| HARH45 | Harmonic ACE+7 Shears
(5-mm diameter x 45-cm long shaft, 360° rotation) | Ethicon |
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193563
Device Name
Medline ReNewal Reprocessed Harmonic ACE+7 Shears (HARH23, HARH36, HARH45)
Indications for Use (Describe)
The Medline ReNewal Harmonic ACE+7 Shears 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, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.
| 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.
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
K193563
Reprocessed Single-Use Device Models Included in Submission:
| Device Model | Device Name | Original
Manufacturer |
|--------------|----------------------------------------------------------------------------|--------------------------|
| HARH23 | Harmonic ACE+7 Shears
(5-mm diameter x 23-cm long shaft, 360° rotation) | Ethicon |
| HARH36 | Harmonic ACE+7 Shears
(5-mm diameter x 36-cm long shaft, 360° rotation) | Ethicon |
| HARH45 | Harmonic ACE+7 Shears
(5-mm diameter x 45-cm long shaft, 360° rotation) | Ethicon |
5
Image /page/5/Picture/2 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The word "MEDLINE" is written in white letters inside the blue square. To the right of the Medline logo is the word "Renewal" written in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" written in smaller, gray letters.
Traditional 510(k) Notification K193563 Medline ReNewal Reprocessed Harmonic AČE+7 Shears
5.0 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/
Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave., Redmond, OR 97756 | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact/
Prepared by | Gail Gassner
Quality Assurance Specialist II, Quality Assurance/Regulatory Affairs
P: 541-516-4193 • F: 541-923-3375 • E: ggassner@medline.com | | |
| Date Prepared | December 20, 2019 | | |
| Device Name
and
Classification | Proprietary/Trade
Name: | Medline ReNewal Reprocessed Harmonic ACE+7
Shears models HARH23, HARH36, and HARH45 | |
| | Common or Usual
Name | Reprocessed ultrasonic scalpel | |
| | Regulatory
Name/Reference | Electrosurgical cutting and coagulation device and
accessories reprocessed, 21 CFR § 878.4400 | |
| | Regulatory Class | Unclassified | |
| | Product Code | NLQ | |
| | Panel | General & Plastic Surgery | |
| Predicate
Device | 510(k) Number | K132612 | |
| | Proprietary or
Trade Name | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH
ADVANCED HEMOSTASIS, HARMONIC ACE +
LAPAROSCOPIC SHEARS 36 CM LENGTH WITH
ADVANCE | |
| | Common or Usual
Name | Ultrasonic surgical instrument | |
| | Regulatory
Name/Reference | Electrosurgical cutting and coagulation device and
accessories reprocessed, 21 CFR § 878.4400 | |
| | Regulatory Class | Unclassified | |
| | Product Code | LFL | |
| | Panel | General & Plastic Surgery | |
| | Manufacturer | Ethicon Endo-Surgery, LLC
4545 Creek Road, Cincinnati, OH 45242 | |
| Device
Description | The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models
HARH23, HARH36, and HARH45) are used for coagulation and
mechanical transection of soft tissue during laparoscopic and open
procedures. The devices allow the surgeon to grasp, coagulate, and
transect soft tissue with a single instrument. The devices are hand-actuated
with a shaft and tissue effector that can be rotated. The energy delivery can
be activated with hand activation or with an optional generator foot switch. | | |
| Indications for
use | The Medline ReNewal Harmonic ACE+7 Shears 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, | | |
| Technological
Characteristics | The technological characteristics and the fundamental scientific technology
of the subject devices are equivalent to the predicate device. The proposed
devices are a reprocessed version of the predicate devices. K132612
Ethicon Harmonic ACE+7 Shears was used as the primary predicate to
support intended use, technological characteristics, and functional
performance specifications. | | |
| Performance
Testing | The functional characteristics of the proposed devices have been evaluated
and found to be equivalent to the predicate devices based on the following
tests:
• electrical safety and electromagnetic compatibility in accordance
with IEC 60601-1 and 60601-1-2;
• simulated use;
• device integrity;
• handle operation;
• shaft knob rotation;
• device recognition;
• cutting time;
• thermal analysis characterization;
• tissue sticking;
• burst pressure;
• histopathology;
• seal quality;
• Cleaning:
o protein,
o carbohydrates,
o endotoxin;
• Biocompatibility:
o cytotoxicity,
o sensitization,
o irritation,
o materials-mediated pyrogen, and
o acute systemic toxicity;
• performance qualification; and
• sterilization validation. | | |
| | Summary Table: Predicate and Medline ReNewal Reprocessed Harmonic ACE+7 Shears
device comparison chart. | | |
| | Predicate | Proposed | Comparison |
| Device
Characteristics | Ethicon Harmonic ACE+7
Shears with Advanced
Hemostasis | Medline ReNewal
Reprocessed Harmonic
ACE+7 Shears | As Stated |
| 510(k) | K132612 | K193563 | N/A |
| Model Numbers | HARH23, HARH36, HARH45 | HARH23, HARH36, HARH45 | Same |
| Common Name | Instrument, Ultrasonic Surgical | Scalpel, Ultrasonic,
Reprocessed | As Stated |
| Regulation No. | 21 CFR § 878.4400 | 21 CFR § 878.4400 | Same |
| Regulatory Class | Unclassified | Unclassified | Same |
| Product Code | LFL | NLQ | As stated |
| Indications for
Use | The Ethicon Harmonic ACE+
7 Shears with Advanced
Hemostasis 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, thoracic, exposure to
orthopedic structures (such as
spine and joint space), sealing
and transection of lymphatic
vessels, and other open and
endoscopic procedures. The
instruments allow for the
coagulation of vessels up to
and including 7 mm in
diameter using the Advanced
Hemostasis hand control
button. | The Medline ReNewal
Reprocessed Harmonic ACE+
7 Shears with Advanced
Hemostasis 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, thoracic, exposure to
orthopedic structures (such as
spine and joint space), sealing
and transection of lymphatic
vessels, and other open and
endoscopic procedures. The
instruments allow for the
coagulation of vessels up to
and including 7 mm in
diameter using the Advanced
Hemostasis hand control
button. | Same |
6
Image /page/6/Picture/2 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of a blue square with a white star-like symbol and the word "MEDLINE" in white letters. To the right of the Medline logo is the Renewal logo, with the word "Renewal" in green and the words "Full Circle Reprocessing" in blue below it. The Renewal logo also has a trademark symbol.
7
Image /page/7/Picture/2 description: The image contains the logo for "ReNewal Full Circle Reprocessing". On the left side of the logo is a blue square with the word "MEDLINE" written in white letters. To the right of the square is the word "ReNewal" written in green letters. Below the word "ReNewal" is the phrase "Full Circle Reprocessing".
Traditional 510(k) Notification K193563 Medline ReNewal Reprocessed Harmonic ÀĆE+7 Shears
8
Image /page/8/Picture/2 description: The image contains the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and is a blue square with a white cross in the center. The Renewal Full Circle Reprocessing logo is on the right side of the image. The word "Renewal" is in green and the words "Full Circle Reprocessing" are in blue.
Traditional 510(k) Notification K193563 Medline ReNewal Reprocessed Harmonic ÀĆE+7 Shears
Summary Table: Predicate and Medline ReNewal Reprocessed Harmonic ACE+7 Shears device comparison chart (concluded).
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristics | Ethicon Harmonic ACE+7 | ||
| Shears with Advanced | |||
| Hemostasis | Medline ReNewal | ||
| Reprocessed Harmonic | |||
| ACE+7 Shears | As stated | ||
| Power Platforma | • HARH23 = Ethicon Endo- | ||
| Surgery Generator G11, | |||
| model GEN11 | |||
| • HARH36 = Ethicon Endo- | |||
| Surgery Generator G11, | |||
| model GEN11 | |||
| • HARH45 = Ethicon Endo- | |||
| Surgery Generator G11, | |||
| model GEN11 | • HARH23 = Ethicon Endo- | ||
| Surgery Generator G11, | |||
| model GEN11 | |||
| • HARH36 = Ethicon Endo- | |||
| Surgery Generator G11, | |||
| model GEN11 | |||
| • HARH45 = Ethicon Endo- | |||
| Surgery Generator G11, | |||
| model GEN11 | Same | ||
| Technological | |||
| Characteristics | The Harmonic ACE+7 Shears | ||
| works in conjunction with the | |||
| Ethicon GEN11 generator. | |||
| The device connects to the | |||
| GEN11 with a handpiece and | |||
| can be operated using finger | |||
| switches on the handle or with | |||
| a foot pedal. Communication | |||
| with the GEN11 is facilitated | |||
| and data is stored by flex | |||
| circuitry in the device handle.b | |||
| A mechanical trigger actuates | |||
| the jaws. | The Harmonic ACE+7 Shears | ||
| works in conjunction with the | |||
| Ethicon GEN11 generator. | |||
| The device connects to the | |||
| GEN11 with a handpiece and | |||
| can be operated using finger | |||
| switches on the handle or with | |||
| a foot pedal. Communication | |||
| with the GEN11 is facilitated | |||
| and data is stored by | |||
| ReNewal Key-integrated flex | |||
| circuitry in the device handle. | |||
| A mechanical trigger actuates | |||
| the jaws. | As stated | ||
| a The Ethicon Endo-Surgery Generator G11, model GEN11 generator was cleared under | |||
| K101990. The generator will not be reprocessed by Medline ReNewal. It is not a part of this | |||
| submission. | |||
| b The flex circuitry in the OEM Harmonic ACE+7 Shears limits the device to a single use. The | |||
| ReNewal Key-integrated flex circuitry in the reprocessed Harmonic ACE+7 Shears enables | |||
| an additional use. | |||
| Based on comparisons of the indications for use, intended use, technological | |||
| characteristics, and performance data to the predicate devices, Medline | |||
| Conclusion | |||
| ReNewal Reprocessed Harmonic ACE+7 Shears models HARH23, HARH36, | |||
| and HARH45 are substantially equivalent to the predicate devices. |