(157 days)
Not Found
No
The summary describes a reprocessed surgical instrument with "Adaptive Tissue Technology," but the description and performance studies focus on mechanical, thermal, and electrical properties, not AI/ML algorithms. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is a surgical instrument used for cutting and coagulating tissue, which is a procedural tool rather than a therapeutic treatment in itself. Its function is to facilitate a surgical procedure, not to directly treat a condition.
No
Explanation: The device is described as a surgical instrument used for cutting and coagulation of soft tissue and vessels during procedures. Its "Intended Use" focuses on performing surgical actions ("soft tissue incisions when bleeding control and minimal thermal injury are desired") rather than on diagnosing conditions or diseases.
No
The device description clearly outlines a physical surgical instrument with a handle, controls, and a working length, indicating it is a hardware device. The performance studies also focus on physical and functional aspects of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical instrument used for cutting and coagulating tissue during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device description details a surgical instrument with a handle, controls, and a working blade. This is consistent with a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) taken from the body. IVDs are designed to provide information about a patient's health status through the examination of such specimens.
Therefore, the Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, 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
The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, orthopedic (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)
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 use, visual inspection, and fatigue testing. Performance testing conducted: Grasping Force, Artery Seal Burst and Tissue Adhesion, Vein Seal Burst and Tissue Adhesion, Electrical and Thermal Safety IEC 60601, Tissue (Jaw) Pad Life, Tissue (Jaw) Pad Removal Force, Thermal Spread and Transection Time. Performance testing shows the Harmonic FOCUS Shears + Adaptive Tissue Technology performs as originally intended. In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, in contact with tissue/bone/dentin and the duration of contact is limited exposure (
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 15, 2019
SterilMed, Inc. Jan Flegeau Associate Director, Regulatory Affairs 5010 Cheshire Parkway N. Suite 2 Plymouth, Minnesota 55446
Re: K190610
Trade/Device Name: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Regulatory Class: Unclassified Product Code: NLQ Dated: March 7, 2019 Received: March 11, 2019
Dear Jan Flegeau:
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
Reprocessed Single-Use Device Models Subject to Clearance:
| OEM
Model
Number | Device Name/Description | Original
Manufacturer | Reprocessed
Model
Number |
|------------------------|----------------------------------------------------|--------------------------|--------------------------------|
| HAR9F | Harmonic FOCUS Shears + Adaptive Tissue Technology | Ethicon | HAR9FR |
3
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190610
Device Name
Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology
Indications for Use (Describe)
The Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
Reprocessed Single-Use Device Models Subject to Clearance:
| OEM
Model
Number | Device Name/Description | Original
Manufacturer | Reprocessed
Model
Number |
|------------------------|----------------------------------------------------|--------------------------|--------------------------------|
| HAR9F | Harmonic FOCUS Shears + Adaptive Tissue Technology | Ethicon | HAR9FR |
5
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Date Prepared: | August 2, 2019 |
|---|---|
| Submitter and | |
| Manufacturer: | Sterilmed, Inc. |
| 5010 Cheshire Parkway N, Suite 2 | |
| Plymouth, MN 55446 | |
| www.sterilmed.com | |
| Manufacturing | |
| Facility Address: | 11400 73rd Avenue |
| North Maple Grove | |
| MN 55369 | |
| Official | |
| Correspondent: | Jan Flegeau |
| Associate Director, Regulatory Affairs | |
| SterilMed, Inc. | |
| Tel: 786-575-5903 | |
| Email: jflegeau@its.jnj.com | |
| Trade Name: | Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue |
| Technology | |
| Regulation Name: | Scalpel, Ultrasonic, Reprocessed |
| Device Classification: | Unclassified |
| Product Code | NLQ |
| Predicate Device: | HARMONIC FOCUS® Shears + Adaptive Tissue Technology |
| (Ethicon K133314) | |
| Device Description: | The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue |
| Technology is a sterile, single-patient use surgical instrument | |
| consisting of a soft grip scissor handle housing assembly with | |
| two hand controls (MIN for minimum power level and MAX | |
| for maximum power level). The instrument's working length is | |
| 9 cm in length with a 16 mm active blade length. The | |
| instrument allows for the cutting and coagulation of vessels up | |
| to and including 5 mm in diameter. | |
| Model Numbers | HAR9FR |
| Indications For Use: | The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue |
| Technology are 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, | |
| otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, | |
| urologic. exposure to orthopedic structures (such as spine and | |
| joint space) and other open procedures. | |
| Technological | |
| Characteristics: | The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue |
| Technology use an EEPROM memory chip that stores device | |
| identification, usage track ing, and operating parameters for use | |
| by the Generator G 11 that provides power for the Harmonic | |
| FOCUS Shears + Adaptive Tissue Technology. 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 as Adaptive Tissue | |
| Technology regulates the delivery of energy. To do this the | |
| generator monitors the thermal condition of the blade during | |
| device activation. | |
| Functional and Safety | |
| Testing: | Reprocessed devices were tested to demonstrate appropriate |
| functional characteristics. Process validation testing was | |
| performed to validate cleaning and sterilization as well as | |
| device packaging. In addition, the manufacturing process | |
| includes visual and validated functional testing of all products | |
| produced. The Reprocessed Harmonic FOCUS Shears + | |
| Adaptive Tissue Technology, are reprocessed no more than | |
| one (1) time. The torque wrench accessories are reprocessed | |
| no more than two (2) times. Each device and accessory are | |
| marked and tracked through the reprocessing cycle. After the | |
| device or torque wrench has reached the maximum number of | |
| reprocessing cycles, one and two, 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 use, visual | |
| inspection, and fatigue testing. Performance testing | |
| conducted: | |
| ● Grasping Force | |
| ● Artery Seal Burst and Tissue Adhesion | |
| ● Vein Seal Burst and Tissue Adhesion | |
| ● Electrical and Thermal Safety IEC 60601 | |
| ● Tissue (Jaw) Pad Life | |
| ● Tissue (Jaw) Pad Removal Force | |
| ● Thermal Spread and Transection Time | |
| Performance testing shows the Harmonic FOCUS | |
| Shears + Adaptive Tissue Technology performs as | |
| originally intended. | |
| In addition, the device was tested for biocompatibility | |
| per ISO 10993-1 for external communicating device, in | |
| contact with tissue/bone/dentin and the duration of | |
| contact is limited exposure ( |