(175 days)
Not Found
No
The summary describes a standard RF vessel sealing system and does not mention any AI or ML components or capabilities.
Yes
The device is intended and described for use in surgical procedures to seal blood vessels, which directly addresses a medical condition (bleeding) and restores bodily functions (hemostasis).
No
The device is described as a surgical vessel sealing system that uses bipolar RF energy to seal blood vessels. Its intended use is for vessel ligation during surgical procedures. There is no mention of it being used to diagnose conditions, diseases, or provide diagnostic information.
No
The device description explicitly states it consists of a generator and a sealer, which are hardware components.
Based on the provided information, the JustRight Surgical™ Vessel Sealing System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles". This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "Vessel Sealing System" consisting of a generator and a sealer instrument. This is a surgical tool used to apply energy to tissue, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for this purpose.
Therefore, the JustRight Surgical™ Vessel Sealing System is a surgical device used during procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
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 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
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image contains a logo for "just:right SURGICAL". The logo features a stylized letter "D" on the left, followed by the word "just:right" in a bold, sans-serif font. Below "just:right" is the word "SURGICAL" in a smaller font size. The overall design is clean and modern.
Premarket Notification 510(k) JustRight Surgical™ Vessel Sealing System November 26, 2012
Page 6-2
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 and |
| K070162 |
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
1
Page 6-3
Image /page/1/Picture/1 description: The image contains a logo for "just.right SURGICAL". The word "just" is in bold, and the word "right" is in a smaller font size. The word "SURGICAL" is in a smaller font size and is located below the word "just". There is a circular design to the left of the text.
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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
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
3
Page 2 - Ms. Michele Lucey
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
4
Page 5-2
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