(113 days)
Not Found
No
The summary describes a vessel sealing system that uses bipolar RF energy. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for surgical procedures to seal blood vessels and vascular bundles, which is a therapeutic intervention.
No
The device is described as a surgical tool used to seal blood vessels during procedures, not to diagnose medical conditions.
No
The device description clearly outlines hardware components: a generator and a sealer instrument with a cord. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "seal blood vessels and vascular bundles" during surgical procedures. This is a therapeutic and surgical function performed directly on the patient's body.
- Device Description: The device is a "Vessel Sealing System" consisting of a generator and a sealer instrument. This describes a surgical tool used for a physical intervention.
- Anatomical Site: The anatomical site is "blood vessels and vascular bundles," which are parts of the living body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device operates in vivo (within the living body) to perform a surgical procedure, which is fundamentally different from the function of an IVD.
N/A
Intended Use / Indications for Use
The JustRight Surgical® Vessel Sealing System is indicated for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required.
The device is contraindicated for use in ENT procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The JustRight Surgical® Vessel Sealing System consists of the JustRight™ Generator and a JustRight™ Sealer. The JustRight™ Generator is designed to provide low power bipolar RF energy for vessel-sealing applications. The JustRight™ Generator is for use only with JustRight™ Sealer instruments. The JustRight™ Sealer is a hand held ring handle design with either a 10 cm or a 20 cm shaft length that is compatible with a 3mm (ID) cannula. The JustRight™ Sealer attaches to the generator via a 10' cord.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric populations
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)
Bench testing of the JustRight Surgical® Vessel Sealing System was performed to evaluate device function and durability. Electrical safety and Electromagnetic Compatibility testing was conducted in accordance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2.
Biocompatibility testing was conducted in accordance with ISO 10993.
Animal testing of the JustRight Surgical® Vessel Sealing System conducted, confirmed device performance to be equivalent to the predicate device.
The results of bench testing performed confirmed that the device performance and characteristics performed as well as the currently marketed device and are consistent with safety and performance requirements for this device type and intended use.
A literature review, including meta-analytics, was conducted to evaluate complication rates noted for vessel sealers in pediatric populations compared to adult populations. In addition, post-market feedback data was collected on the JustRight Surgical® Vessel Sealing System. This information supports the expansion of the device indication for use in the pediatric population.
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.
JustRight Surgical® Vessel Sealing System K123662, LigaSure™ Vessel Sealing System K981916, Force Triad™ Electrosurgical Generator K070162
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
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
JustRight Surgical LLC Ms. Jenifer Kennedy Director of Research 357 S. McCaslin Boulevard, Suite 120 Louisville, Colorado 80027
Re: K160602
Trade/Device Name: JustRight Surgical Vessel Sealing System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: May 24, 2016 Received: May 26, 2016
Dear Ms. Kennedy:
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 devicerelated adverse events) (21 CFR 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 1000-1050.
1
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,
David Krause -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
JustRight Surgical® Vessel Sealing System
Indications for Use (Describe)
The JustRight Surgical® Vessel Sealing System is indicated for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediations, wherever vessel ligation is required.
The device is contraindicated for use in ENT procedures.
Type of Use (Select one or both, as applicable)
S
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K160602 510(K) SUMMARY Prepared In accordance with 21 CFR Part 807.92
Submitter Information
| Submitter's Name: | JustRight Surgical LLC |
|---|---|
| Address: | 357 S. McCaslin Boulevard #120 |
| Louisville, CO 80027 | |
| Telephone: | 720-287-7130 |
| Fax: | 720-287-7130 |
| Contact Person: | Jenifer Kennedy |
| Telephone: | 720-287-7143 |
| 720-287-7135 (fax) | |
| Date Prepared: | June 21, 2016 |
| Device Trade Name: | JustRight Surgical® Vessel Sealing System |
| Classification: | Class II |
| Product Code(s): | GEI |
| Common Name: | Electrosurgical, Cutting & Coagulation and Accessories |
| Regulation Number(s): | 878.4400 |
| Predicate Devices: | JustRight Surgical® Vessel Sealing System K123662 |
| LigaSure™ Vessel Sealing System K981916 | |
| Force Triad™ Electrosurgical Generator K070162 |
Intended Use:
The JustRight Surgical® Vessel Sealing System is indicated for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required.
The device is contraindicated for use in ENT procedures.
Device Description/Technological Characteristics:
The JustRight Surgical® Vessel Sealing System consists of the JustRight™ Generator and a JustRight™ Sealer. The JustRight™ Generator is designed to provide low power bipolar RF energy for vessel-sealing applications. The JustRight™ Generator is for use only with JustRight™ Sealer instruments. The JustRight™ Sealer is a hand held ring handle design with either a 10 cm or a 20 cm shaft length that is compatible with a 3mm (ID) cannula. The JustRight™ Sealer attaches to the generator via a 10' cord.
Performance Data:
Bench testing of the JustRight Surgical® Vessel Sealing System was performed to evaluate device function and durability. Electrical safety and Electromagnetic Compatibility testing was conducted in accordance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2.
Biocompatibility testing was conducted in accordance with ISO 10993.
4
Animal testing of the JustRight Surgical® Vessel Sealing System conducted, confirmed device performance to be equivalent to the predicate device.
Conclusions Drawn From Non-clinical Performance Testing
The results of bench testing performed confirmed that the device performance and characteristics performed as well as the currently marketed device and are consistent with safety and performance requirements for this device type and intended use.
Safety and Efficacy Considerations
A literature review, including meta-analytics, was conducted to evaluate complication rates noted for vessel sealers in pediatric populations compared to adult populations. In addition, post-market feedback data was collected on the JustRight Surgical® Vessel Sealing System. This information supports the expansion of the device indication for use in the pediatric population.
Substantial Equivalence:
The current JustRight Surgical® Vessel Sealing System is very similar to the cleared JustRight Surgical® Vessel Sealing System. The indication for use statement has been modified to include an indication for pediatric use in general and laparoscopic surgical procedures. The literature review and postmarket feedback evaluations provide supporting safety and efficacy information for the pediatric indication There is no change to the tissue types of procedures where the JustRight Surgical® Vessel Sealing System is indicated. The technical specifications of the current device are the same as the JustRight predicate device.
In consideration of the evidence provided to support the pediatric indication, and the comparison of both technical and use features of the JustRight Surgical® Vessel Sealing System, the subject device is substantially equivalent to the JustRight Surgical® Vessel Sealing System (K123662) and Covidien LigaSure™ Vessel Sealing System (K981916, K070162).