(194 days)
Not Found
No
The description mentions "Adaptive Tissue Technology" which modulates power output based on tissue identification, but this is described as a function of the generator and instrument interaction, not explicitly as AI or ML. There is no mention of AI, ML, DNN, training sets, or test sets.
Yes.
The device is used for soft tissue incisions, coagulation of vessels, and transection of lymphatic vessels, which are all therapeutic interventions.
No
This device is described as an instrument for soft tissue incisions, coagulation, and mechanical transection, clearly indicating its use in surgical procedures rather than for diagnosis.
No
The device description clearly outlines a physical instrument with a handle, activation buttons, and a mechanism for feedback. It also mentions a disposable torque wrench and extensive bench and laboratory testing involving physical properties and performance. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for cutting, coagulating, and sealing soft tissue and vessels within the body during surgical procedures. This is an in vivo application.
- Device Description: The description details a surgical tool with a handle, activation buttons, and mechanisms for tissue manipulation and energy delivery. This aligns with a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device operates directly on tissue within the body.
N/A
Intended Use / Indications for Use
The Reprocessed HARMONIC ACE®+7, 5 mm Diameter 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.
Product codes
NLO, NLQ
Device Description
Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an ergonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. Each instrument is shipped with one sterile, single-use, disposable torque wrench.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, orthopedic structures (such as spine and joint space), lymphatic vessels.
Indicated Patient Age Range
pediatric (mentioned in the Intended Use, although a specific age range isn't given)
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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis. This included the following tests:
- Biocompatibility
- Validation of Reprocessing
- Sterilization Validation
- Functional Performance Tests
- Blade to Clamp Arm Angle
- Actuating Trigger Force
- MIN/MAX Button Activation Force
- Advanced Hemostasis (AH) Button Activation Force
- Rotation Knob Force – Actuating Trigger Disengaged
- Rotation Knob Force Actuating Trigger Engaged
- Jaw Clamp Force
- Tissue Retention Force
- Shaft Straightness
- ATT Functionality and Transection Time
- Burst Pressure
- Maximum Jaw and Shaft Temperature
- Reliability Testing
- Electromagnetic Compatibility & Electrical Safety Testing
- Packaging Validation
- Pre-Clinical Testing
- Acute Animal Study
- Chronic Animal Study
The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1-2 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 to 7mm, including thermal spread, transection time, burst pressure, device functionality, and device reliability.
The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate devices and operate as originally intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2021
Stryker Sustainability Solutions Aphrodeja Crutch Sr. Regulatory Affairs Specialist 1810 W. Drake Dr. Tempe, Arizona 85283
Re: K202554
Trade/Device Name: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis Regulatory Class: Unclassified Product Code: NLO Dated: February 16, 2021 Received: February 19, 2021
Dear Aphrodeja Crutch:
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-devices/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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
| OM | Model
Number | Device Name/Description | Shaft
Diameter | Shaft
Length |
|---------|-----------------|----------------------------------------------------|-------------------|-----------------|
| Ethicon | HARH23 | Harmonic ACE +7 Shears with Advanced
Hemostasis | 5mm | 23cm |
| Ethicon | HARH36 | Harmonic ACE +7 Shears with Advanced
Hemostasis | 5mm | 36cm |
| Ethicon | HARH45 | Harmonic ACE +7 Shears with Advanced
Hemostasis | 5mm | 45cm |
Reprocessed Single-Use Device Models Subject to Clearance :
3
Page 1 of 1
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K202554
Device Name
Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis
Indications for Use (Describe)
The Reprocessed HARMONIC ACE®+7, 5 mm Diameter 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, 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.
| 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
SECTION 5: 510(k) SUMMARY
Submitter:
Stryker Sustainability Solutions (SSS) 1810 W. Drake Drive Tempe, Arizona 85283
Contact:
Aphrodeja Crutch, B.A., Pre-law/Legal Studies Sr. Regulatory Affairs Specialist 404.993.1981 (c) 480-763-5310 (f) aphrodeja.crutch@stryker.com
Date of Preparation: September 1, 2020
Name of Device:
| Trade/Proprietary Name: | Reprocessed Harmonic ACE® +7, 5mm Diameter Shears with
Advanced Hemostasis (HARH23, HARH36, HARH45) |
|-----------------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Scalpel, Ultrasonic, Reprocessed |
| Classification Information: | Class: Unclassified
Unclassified Reason: Pre-Amendment
Product Code: NLQ |
| Model Numbers: | HARH23, HARH36, HARH45 |
Predicate Devices:
| Model
Number | 510(k)
Number | 510(k) Title | Original
Manufacturer |
|----------------------------|------------------|--------------------------------------------------|-------------------------------|
| HARH23
HARH36
HARH45 | K132612 | HARMONIC ACE+ Shears with Advanced
Hemostasis | Ethicon Endo-
Surgery, LLC |
Device Description:
Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an ergonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate.
5
Each instrument is shipped with one sterile, single-use, disposable torque wrench.
| Model Number | Description | Original Manufacturer |
|---|---|---|
| HARH23 | HARMONIC ACE+7 Shears with Advanced Hemostasis 5mm Diameter, 23cm Length | Ethicon Endo-Surgery, LLC |
| HARH36 | HARMONIC ACE+7 Shears with Advanced Hemostasis 5mm Diameter, 36cm Length | Ethicon Endo-Surgery, LLC |
| HARH45 | HARMONIC ACE+7 Shears with Advanced Hemostasis 5mm Diameter, 45cm Length | Ethicon Endo-Surgery, LLC |
Intended Use:
The Reprocessed HARMONIC ACE®+7, 5 mm Diameter 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.
Summary of Technological Characteristics in Comparison to the Predicate Devices:
The design, materials, and intended use of Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are equivalent to the predicate devices. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, SSS' reprocessing of HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis 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.
Substantial Equivalence Table Ethicon Endo-Surqery HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis and Stryker Sustainability Solutions Reprocessed (SSS) HARMONIC ACE@+7, 5 mm Diameter Shears with Advanced Hemostasis:
6
| Characteristic | Ethicon Endo-Surgery
HARMONIC ACE®+7, 5 mm
Diameter Shears with
Advanced Hemostasis | Stryker Sustainability
Solutions (SSS)
Reprocessed HARMONIC
ACE®+7, 5 mm Diameter
Shears with Advanced
Hemostasis |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The HARMONIC ACE®+7, 5
mm Diameter 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 Reprocessed
HARMONIC ACE®+7, 5 mm
Diameter 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. |
| Contraindications for
Use | • The instruments are not
indicated for incising bone.
• The instruments are not
intended for contraceptive
tubal occlusion. | • The instruments are not
indicated for incising bone.
• The instruments are not
intended for contraceptive
tubal occlusion. |
| Sterility | Sterile by Ethylene Oxide | Sterile by Ethylene Oxide |
| Pyrogen Free | No | No |
| Expiration Date | The expiration date is
provided on the device
package labels. The date of
manufacture is not provided
on the device package
labels, thus, the shelf life is
unknown. | The expiration date is
provided on the device
package labels. The
expiration date is labeled as
three (3) years from the
date of manufacture. |
| Uses | Single Patient Use | Single Patient Use |
| Characteristic | Ethicon Endo-Surgery
HARMONIC ACE®+7, 5 mm
Diameter Shears with
Advanced Hemostasis | Stryker Sustainability
Solutions (SSS)
Reprocessed HARMONIC
ACE®+7, 5 mm Diameter
Shears with Advanced
Hemostasis |
| Generator | Generator G11 (GEN11) software version 2013_I or later | Generator G11 (GEN11) software version 2013_I or later |
| Device Materials | Refer to Table 10-2 for a list of patient-contacting materials. | Refer to Table 10-2 for a list of patient-contacting materials. |
| Device Packaging | Primary Packaging is comprised of a PETG sealed thermoformed tray. One (1) device is secured in the tray. An adhesive-coated DuPont 1073B Tyvek Lid is sealed to the tray to create a sterile barrier system. | Primary Packaging is comprised of a PETG sealed thermoformed tray. One (1) device is secured in the tray. An adhesive-coated DuPont 1073B Tyvek Lid is sealed to the tray to create a sterile barrier system. |
| | Secondary Packaging is comprised of solid bleached sulfate folding shelf carton. Six (6) Primary Packages are inserted into the Secondary Package.
Tertiary Packaging is comprised of a corrugate shipping carton. One (1) Secondary Package is placed in a corrugate shipping carton. | Secondary Packaging is comprised of solid bleached sulfate folding shelf carton. Six (6) Primary Packages are inserted into the Secondary Package.
Tertiary Packaging is comprised of a corrugate shipping and sterilization carton. One (1) Secondary Package is placed in a corrugate shipping carton. |
| Substitute Components | Refer to Table 10-9 for list of substitute components. | Refer to Table 10-9 for list of substitute components. |
7
Performance Data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis. This included the following tests:
- Biocompatibility ●
- Validation of Reprocessing
- Sterilization Validation ●
- Functional Performance Tests
- Blade to Clamp Arm Angle o
- o Actuating Trigger Force
8
- MIN/MAX Button Activation Force o
- Advanced Hemostasis (AH) Button Activation Force O
- o Rotation Knob Force – Actuating Trigger Disengaged
- Rotation Knob Force Actuating Trigger Engaged O
- Jaw Clamp Force o
- O Tissue Retention Force
- Shaft Straightness o
- ATT Functionality and Transection Time O
- O Burst Pressure
- Maximum Jaw and Shaft Temperature o
- Reliability Testing o
- Electromagnetic Compatibility & Electrical Safety Testing ●
- Packaging Validation ●
- Pre-Clinical Testing ●
- o Acute Animal Study
- o Chronic Animal Study
The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1-2 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 to 7mm, including thermal spread, transection time, burst pressure, device functionality, and device reliability.
The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate devices and operate as originally intended.
The Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are reprocessed no more than two (2) times. Each reprocessed device is tracked with a Stryker pad print on the device indicating the device has been reprocessed. On the second turn a line will be added on top of the original pad print indicating two reprocessing cycles. Once the device reaches the maximum number of reprocessing cycles, it is rejected and taken out of service. Reprocessing is conducted only by Stryker Sustainability Solutions. Stryker Sustainability Solutions restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Stryker Sustainability Solutions (SSS) concludes that the Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis is at least as safe and effective as the predicate device as described herein.