(175 days)
The JustRight Surgical™ Vessel Sealing System is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter wherever vessel ligation is required.
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 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.
The JustRight Surgical™ Vessel Sealing System demonstrated its performance through a series of bench and animal studies to support its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or specific numerical performance targets for the device. Instead, it relies on demonstrating equivalence to predicate devices through various tests.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Function & Durability | Not explicitly defined as quantitative criteria, but implicitly means meeting expected operational standards. | Bench testing of the JustRight Surgical™ Vessel Sealing System was performed to evaluate device function and durability. The document states that the testing was performed "to evaluate device function and durability," implying successful operation within expected parameters. Specific results or metrics are not provided. |
| Electrical Safety | Compliance with IEC 60601-1-1 | Testing was conducted and found to be in accordance with IEC 60601-1-1. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Testing was conducted and found to be in accordance with IEC 60601-1-2. |
| Biocompatibility | Compliance with ISO 10993 | Testing was conducted and found to be in accordance with ISO 10993. |
| Vessel Sealing Performance | Equivalence to predicate device (Valleylab Ligasure™ Vessel Sealing System) in ability to seal blood vessels and vascular bundles up to 5 mm. | Animal testing of the JustRight Surgical™ Vessel Sealing System was conducted, which "confirmed device performance to be equivalent to the predicate device." No specific quantitative metrics (e.g., burst pressure, thermal spread) are provided, but the equivalence implies meeting the performance standards of the predicate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size for the animal testing. It only mentions "Animal testing."
- Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by JustRight Surgical LLC. The information provided is retrospective, as it's part of a premarket notification submitted to the FDA after the tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies described are technical performance tests (bench and animal), not diagnostic or interpretative studies requiring expert ground truth in the typical sense (e.g., radiologists interpreting images). The "ground truth" for the animal study would be the physiological outcomes observed by the researchers/veterinarians involved.
4. Adjudication method for the test set:
This information is not provided. Given the nature of the bench and animal testing, a formal adjudication method as understood in clinical trials or diagnostic studies (e.g., 2+1, 3+1) is not typically applicable. The results would be objectively measured or observed by the testing personnel.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (vessel sealing system), not an AI-powered diagnostic tool, and therefore human reader performance/improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a medical instrument that delivers energy for vessel sealing; it is not an algorithm or AI system. Therefore, a "standalone algorithm performance" assessment is not applicable. The performance evaluated was the direct function of the device itself.
7. The type of ground truth used:
- Bench Testing: The ground truth for bench testing (electrical safety, EMC, biocompatibility, function, durability) would be objective measurements against established engineering standards (IEC, ISO) and internal design specifications.
- Animal Testing: The "ground truth" for the animal testing would be the observed physiological outcomes and performance metrics (e.g., effectiveness of vessel sealing) measured directly in the animal models, compared against the performance of the predicate device. This is essentially outcomes data within a controlled animal study.
8. The sample size for the training set:
The device is a hardware system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
As there is no training set for an AI/ML algorithm, this question is not applicable.
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Premarket Notification 510(k) JustRight Surgical™ Vessel Sealing System November 26, 2012
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MAY 2 2 2013
510(K) SUMMARY
Submitter Information
| Submitter's Name: | JustRight Surgical LLC |
|---|---|
| Address: | 6235 Gunpark Drive #G |
| Boulder, | CO 80301 |
| Telephone: | 720-287-7130 |
| Fax: | 720-287-7130 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | November 26, 2012 |
| Device Trade Name: | JustRight Surgical™ Vessel Sealing System |
| Classification: | Class II |
| Product Code(s): | GEI |
| Regulation Number(s): | 878.4400 |
| Predicate Devices: | Valleylab Ligasure™ Vessel Sealing System, K981916 andK070162 |
Intended Use:
The JustRight Surgical™ Vessel Sealing System is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter wherever vessel ligation is required.
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 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
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Premarket Notification 510(k) JustRight Surgical™ Vessel Sealing System November 26, 2012
Compatibility testing was conducted in accordance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2.
Biocompatibilty 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.
Substantial Equivalence:
JustRight Surgical™ Vessel Sealing System and the Valleylab Ligasure™ Vessel Sealing System have the same intended use and similar indications, technological characteristics, and principals of operation. Thus, the JustRight Surgical™ Vessel Sealing System is substantially equivalent to the Valleylab Ligasure™ Vessel Sealing System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
JustRight Surgical % Ms. Michele Lucey Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing Newbury, NH 03255
Re: K123662
Trade/Device Name: Justright Surgical™ Vessel Sealing System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting & Coagulation and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 11, 2013 Received: April 23, 2013
Dear Ms. Lucey:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
May 22, 2013
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, FOR
Peter DJ Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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just
SURGICAL
Premarket Notification 510(k) JustRight Surgical™ Vessel Sealing System November 26, 2012
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: JustRight Surgical™ Vessel Sealing System
Indications for Use:
The JustRight Surgical™ Vessel Sealing System is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter wherever vessel ligation is required.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua: C. Nipper -S
For
(Division Sign-Off)
Division of Surgical Devices
510(k) Number __ K123662
§ 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.