(24 days)
Not Found
No
The description focuses on the mechanical and electrical functions of the device, specifically converting electrical energy to mechanical motion and a simple procedure counter. There is no mention of AI, ML, or any complex data processing or learning capabilities.
Yes.
The device is indicated for soft tissue incisions with desired bleeding control and minimal thermal injury, functioning as an adjunct to or substitute for other surgical tools like electrosurgery, lasers, and steel scalpels, which are therapeutic medical procedures.
No
The device is described as being indicated for "soft tissue incisions when bleeding control and minimal thermal injury are desired" and used as an "adjunct to or substitute for electrosurgery, lasers, and steel scalpels." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly details physical hardware components (Hand Piece, cord, Blade Wrench, Test Tip) that convert electrical energy to mechanical motion and are packaged non-sterile, requiring sterilization. While there is mention of software compatibility and a programmed counter, the core function and components are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for "soft tissue incisions when bleeding control and minimal thermal injury are desired." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details how the hand piece converts electrical energy to mechanical motion for surgical instruments. It does not mention any interaction with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
The device is clearly designed for surgical use, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The HARMONIC® Blue Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.
The HARMONIC® Gray Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
HARMONIC® Blue Hand Piece: The HARMONIC® Blue Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blade. The Blue Hand Piece is intended for use exclusively with a compatible HARMONIC Generator. The Blue Hand Piece is permanently attached to a blue cord which connects to the front of the Generator. The Blue Hand Piece is a re-useable instrument with a limited service life. The Blue Hand Piece is programmed with a counter to limit the service life to 100 procedures. The generator will give a Hand Piece error after 100 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.
HARMONIC® Gray Hand Piece: The HARMONIC® Gray Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blades. This Hand Piece is intended for use with a compatible Ethicon Generator. The Hand Piece is permanently attached to a cord which connects to the front of the Generator. The Hand Piece is a re-useable instrument with a limited service life. The Hand Piece is programmed with a counter to limit the service life to 95 procedures. The generator will give a Hand Piece error after 95 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later. The Hand Piece is packaged with a Blade Wrench and Test Tip. The Blade Wrench is used to secure instrument blades to the Hand Piece. The Hand Piece. Blade Wrench, and Test Tip are packaged non-sterile and must be sterilized per their insert instructions prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
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)
Risk analyses for each device modification are provided. Verification testing, Biocompatibility evaluation and Electrical testing were conducted to confirm device modifications do not raise new issues of safety or effectiveness. Clinical studies were not required to demonstrate substantial equivalence. Risk analyses show that the risk profile of the new devices has not changed as a result of the described changes while having the same intended use as the predicate devices. Verification testing, Biocompatibility evaluation and Electrical testing conducted, confirm the performance of the new devices is consistent with the predicate devices and does not raise any new questions of safety and effectiveness.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
May 21, 2021
Ethicon Endo-Surgery, LLC % Ms. Ruth James, MSc, RAC Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery, LLC. 4545 Creek Road Cincinnati, OHIO 45242
Re: K211273
Trade/Device Name: Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray Regulatory Class: Unclassified Product Code: LFL Dated: April 26, 2021 Received: April 27, 2021
Dear Ms. James:
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.
1
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 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 (QS) 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 medical devices and radiation-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
Indications for Use
510(k) Number (if known) K211273
Device Name HARMONIC® Blue Hand Piece HARMONIC® Gray Hand Piece
Indications for Use (Describe)
The HARMONIC® Blue Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.
The HARMONIC® Gray Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.
| 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) |
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Image /page/3/Picture/0 description: The image shows the Ethicon Endo-Surgery logo. The logo consists of a grid of red circles on the left and the text "Ethicon Endo-Surgery" in gray on the right. Below the text is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969
K211273
510(k) Summary
| Submitter Information: | Ethicon Endo-Surgery, LLC
475 Calle Street
Guaynabo, PR 00969 |
| ------------------------ | --------------------------------------------------------------------- |
|---|
Application Correspondent
Ms. Ruth James MSc, RAC. Sr. Regulatory Affairs Program Lead Ethicon Endo-Surgery, LLC. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-3118 Fax: (513) 337-1122 Email: rjames15@its.jnj.com
Date Prepared May 20, 2021
| Device Trade Name: | HARMONIC® Blue Hand Piece
HARMONIC® Gray Hand Piece |
|--------------------------------|-----------------------------------------------------------|
| Models: | HARHPBL, HARHPBLCN (Blue)
HARHPGR, HARHPGRCN
(Gray) |
| Device Class: | Unclassified |
| Panel: | II |
| Classification (Product) Code: | 79, General & Plastic Surgery
LFL |
Legally Marketed Predicate Devices:
This predicate has not been subject to a design-related recall.
4
Device Description
HARMONIC® Blue Hand Piece
The HARMONIC® Blue Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blade. The Blue Hand Piece is intended for use exclusively with a compatible HARMONIC Generator. The Blue Hand Piece is permanently attached to a blue cord which connects to the front of the Generator.
The Blue Hand Piece is a re-useable instrument with a limited service life. The Blue Hand Piece is programmed with a counter to limit the service life to 100 procedures. The generator will give a Hand Piece error after 100 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.
HARMONIC® Gray Hand Piece
The HARMONIC® Gray Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blades. This Hand Piece is intended for use with a compatible Ethicon Generator.
The Hand Piece is permanently attached to a cord which connects to the front of the Generator.
The Hand Piece is a re-useable instrument with a limited service life. The Hand Piece is programmed with a counter to limit the service life to 95 procedures. The generator will give a Hand Piece error after 95 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.
The Hand Piece is packaged with a Blade Wrench and Test Tip. The Blade Wrench is used to secure instrument blades to the Hand Piece. The Hand Piece. Blade Wrench, and Test Tip are packaged non-sterile and must be sterilized per their insert instructions prior to use.
5
Indications for Use for new devices (identical to predicates)
The HARMONIC® Blue Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.
The HARMONIC® Gray Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.
Comparison of technological characteristics with the predicate device
At a high level, the new and predicate devices are based on the following same technological elements:
| Characteristic | New Devices | Legally marketed Predicate
Devices
K063192, K002906 |
|------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------|
| Indications for Use | Identical | Identical |
| Contraindications | Identical | Identical |
| Non-Sterile, Single Patient Use | Yes | Identical |
| Bio-Compatibility of Materials:
All tissue-contacting materials comply
with ISO 10993-1. | Yes | Yes |
| Packaging Method | Identical | Identical |
| Device Operation | Identical | Identical |
The following technological differences exist between the new and predicate devices:
- . The new Hand Pieces have a standard connector (tear-drop) interface to GEN11 generators.
- . The new Hand Pieces are only compatible with GEN11 operating 2018-1 software and later generators.
- . The Electrically erasable programmable read-only memory (EEPROM) in the Hand Pieces has been upgraded with cybersecurity improvements.
- . The cable design has been harmonized for both Blue and Gray Hand Pieces.
- . The cable components have been modified to improve hand activation durability
- . There is a new protective end cap, used in packaging, for the Gray Hand Piece.
6
Performance Data
Risk analyses for each device modification are provided. Verification testing, Biocompatibility evaluation and Electrical testing were conducted to confirm device modifications do not raise new issues of safety or effectiveness.
Clinical studies were not required to demonstrate substantial equivalence.
Conclusions
Risk analyses show that the risk profile of the new devices has not changed as a result of the described changes while having the same intended use as the predicate devices. Verification testing, Biocompatibility evaluation and Electrical testing conducted, confirm the performance of the new devices is consistent with the predicate devices and does not raise any new questions of safety and effectiveness.