K Number
K161086
Device Name
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
Manufacturer
Date Cleared
2016-09-20

(155 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Harmonic Shears with 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, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Device Description
The Reprocessed Harmonic Shears with Adaptive Tissue Technology 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 shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The device includes a torque wrench as an accessory piece (the torque wrench is designed to ensure that the hand piece is properly secured to the device.
More Information

No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing for analysis or decision-making. The "Adaptive Tissue Technology" is mentioned in the predicate device name, but the description focuses on the reprocessing and functional aspects of the device, not on any intelligent or learning capabilities.

No.
Explanation: The device is used for soft tissue incisions, coagulation, and mechanical transection, which are surgical procedures, not therapeutic treatments.

No

The device is described as surgical shears used for cutting and coagulating soft tissue, not for diagnosing conditions. Its intended use focuses on therapeutic procedures rather than diagnostic ones.

No

The device description clearly outlines a physical surgical instrument (Harmonic Shears) used for coagulation and mechanical transection of soft tissue. It mentions hand-actuation, a shaft, tissue effector, and accessories like a torque wrench. This is a hardware device, not software-only.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use describes the device being used for "soft tissue incisions" and "coagulation and mechanical transection of soft tissue" during surgical procedures. This is a direct interaction with the patient's body for therapeutic purposes.
  • Device Description: The description details a surgical instrument used to grasp, coagulate, and transect tissue. This is consistent with a surgical tool, not a device used to examine specimens from the body.
  • Lack of IVD Indicators: There is no mention of analyzing samples from the body (blood, urine, tissue samples, etc.), diagnostic testing, or providing information for diagnosis.

IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.

N/A

Intended Use / Indications for Use

The Reprocessed Harmonic Shears with 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, thoracic, 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)

NUJ

Device Description

The Reprocessed Harmonic Shears with Adaptive Tissue Technology 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 shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.
The device includes a torque wrench as an accessory piece (the torque wrench is designed to ensure that the hand piece is properly secured to the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue, orthopedic structures (spine and joint space)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon, laparoscopic and open procedures

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)

Functional and Safety Testing: Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced. Where appropriate prior validation testing of previously cleared Reprocessed Harmonic Shears (K132566) was utilized for the same reprocessing procedures, equipment, and sterilization processing. The Reprocessed Harmonic Shears with Adaptive Tissue Technology are reprocessed no more than one (1) time. The torque wrench accessories are reprocessed no more than five (5) times. Each device and accessory is marked and tracked through the reprocessing cycle. After the device or torque wrench has reached the maximum number of reprocessing cycles, one and five, respectively, it is rejected from further reprocessing.

Specific non-clinical tests performed included: cleaning validation, sterilization verification, ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf-life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated Electrical Safety Device Functionality Vessel Seal Burst (Static and Burst Pressure) Vessel Seal Thermal Spread Drop Fluid Ingress Pad Retention Pad Failure Clamp Force
Performance testing shows the reprocessed Harmonic Shears with Adaptive Tissue Technology to perform as originally intended.
In addition, the device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 20, 2016

Sterilmed, Inc. Ms. Neelu Gibson Senior Director, Regulatory Affairs 5010 Cheshire Parkway, Suite 2 Plymouth, Minnesota 55446

Re: K161086

Trade/Device Name: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: August 19, 2016 Received: August 22, 2016

Dear Ms. Gibson:

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

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related adverse events) (21 CFR Part 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 Parts 1000-1050.

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,

Christopher J. Ronk -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

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Indications for Use

510(k) Number (if known) K161086

Device Name

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23 cm)

Indications for Use (Describe)

The Reprocessed Harmonic Shears with 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, thoracic, 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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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K161086 Device Name and Model Numbers

Device NameModel Number
Reprocessed Harmonic ACE®+ Shears, 5 mm Diameter, 23cm Length, With Adaptive Tissue TechnologyHAR23R
Reprocessed Harmonic ACE®+ Shears, 5 mm Diameter, 36cm Length, With Adaptive Tissue TechnologyHAR36R

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Image /page/4/Picture/0 description: The image shows the logo for STERILMED. The logo consists of a stylized green and blue circular arrow on the left, followed by the word "STERILMED" in black and light blue lettering. The first part of the word, "STERIL", is in black, while the "MED" is in a lighter blue color.

K161086

510(k) SUMMARY

| Submitter and
Manufacturer: | Sterilmed, Inc.
5010 Cheshire Parkway N, Suite 2
Plymouth, MN 55446
www.sterilmed.com |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official
Correspondent: | Neelu Gibson
Sr. Director, Regulatory Affairs (RAC)
Sterilmed, Inc.
Tel: 908-705-3160
Fax: 763-488-4576
Email: ngibson9@its.jnj.com |
| Date of
Submission: | 15 March 2016 |
| Trade Name: | Reprocessed Harmonic Shears with Adaptive Tissue Technology (23 cm),
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm) |
| Common Name: | Reprocessed Harmonic Shears with Adaptive Tissue Technology |
| 510(k) Number: | K161086 |
| Device
Classification: | Name: Electrosurgical cutting and coagulation device and accessories.
Regulation: 21CFR 878-4400
Pro Code: NUJ
Class: Class II |
| Predicate Device: | Harmonic ACE Shears + Adaptive Tissue Technology (K121550). |
| Device
Description: | The Reprocessed Harmonic Shears with Adaptive Tissue Technology 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 shaft and tissue effector that can be rotated.
The energy delivery can be activated with hand activation or with an
optional generator foot switch.
The device includes a torque wrench as an accessory piece (the torque
wrench is designed to ensure that the hand piece is properly secured to the
device. |
| Indications
for Use: | The Reprocessed Harmonic Shears with 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, thoracic, exposure to orthopedic
structures (such as spine and joint space) and other open and endoscopic
procedures. |
| Technological
Characteristics: | The reprocessed Harmonic Shears with Adaptive Tissue Technology have
the same technological and performance characteristics as the predicate
devices, K121550. The reprocessed Harmonic Shears with Adaptive
Tissue Technology incorporate an ergonomic handle and tapered blade
geometry. Similar to the predicate models, each of these reprocessed
devices includes an EEPROM memory chip that stores device
identification, usage tracking, and operating parameters for use by the
Ethicon Endo-Surgery, Inc. Generator 11 generator that provides power
for the devices. |
| | Adaptive Tissue Technology refers to the power output algorithm that is
utilized by the devices. During use, the Adaptive Tissue Technology
algorithm parameters stored on the device EEPROM are read by the
generator and used to reduce the power (current) to the instrument and
provide a secondary, higher pitched generator activation tone when there
is little or no tissue between the instrument blade and tissue pads. To do
this the generator monitors the thermal condition of the blade during
device activation. |
| Functional
and Safety
Testing: | Representative samples of reprocessed devices were tested to
demonstrate appropriate functional characteristics. Process validation
testing was performed to validate the cleaning and sterilization
procedures as well as device packaging. In addition, the manufacturing
process includes visual and validated functional testing of all products
produced. Where appropriate prior validation testing of previously
cleared Reprocessed Harmonic Shears (K132566) was utilized for the
same reprocessing procedures, equipment, and sterilization processing.
The Reprocessed Harmonic Shears with Adaptive Tissue Technology are
reprocessed no more than one (1) time. The torque wrench accessories
are reprocessed no more than five (5) times. Each device and accessory
is marked and tracked through the reprocessing cycle. After the device
or torque wrench has reached the maximum number of reprocessing
cycles, one and five, respectively, it is rejected from further reprocessing. |
| Summary of
Non-Clinical
Tests Conducted: | Specific non-clinical tests performed included: cleaning validation,
sterilization verification, ethylene oxide residual testing (ISO 10993-7),
packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and
shelf-life validation (ASTM 1980-07). In addition, validation of
functional performance (bench testing) was performed through simulated Electrical Safety Device Functionality Vessel Seal Burst (Static and Burst Pressure) Vessel Seal Thermal Spread Drop Fluid Ingress Pad Retention Pad Failure Clamp Force |
| | Performance testing shows the reprocessed Harmonic Shears with
Adaptive Tissue Technology to perform as originally intended.
In addition, the device was tested for biocompatibility per ISO 10993-
1 for short duration contact with blood (