(150 days)
Not Found
No
The device description explicitly states "manual, instruments" and there is no mention of AI, ML, or any computational processing in the provided text.
No
The devices are surgical instruments used to perform specific functions during surgical procedures, not to treat or cure a disease or condition.
No
The device description indicates it performs surgical functions like cutting, grasping, or suturing, which are therapeutic interventions, not diagnostic ones. There is no mention of it being used to identify or determine a medical condition.
No
The device description explicitly states it is a family of manual, reusable instruments consisting of physical components like Clamps, Forceps, Scissors, etc., which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instruments are designed to perform surgical functions during open, mini-open, or endoscopic surgical procedures. This involves direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The description lists instruments like clamps, forceps, scissors, etc., which are tools used in surgical procedures, not for analyzing samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Manually operated minimally invasive General & Plastic Surgery Instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.
Product codes
GCJ
Device Description
Sontec Instruments are a family of manual, instruments consisting of Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors and Suction Tips. These reusable devices are packaged non-sterile and are steam sterilizable.
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
Non-clinical tests submitted or relied upon: Cleaning, Thermal Disinfection and Steam Sterilization Validations of Subject Reusable Hand Held Surgical Instruments
Clinical tests submitted or relied upon: None
Key Metrics
Not Found
Predicate Device(s)
K120012, K110121, K945474, K925198
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Sontec Instruments Inc. % Mr. Charles Hart Principle Consultant Hart Consulting LLC 2964 Redhaven Way Littleton, Colorado 80126
Re: K152400
Trade/Device Name: General & Plastic Surgery Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: December 21, 2015 Received: December 21, 2015
Dear Mr. Hart:
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
1
related 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.
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.
Jennifer R. Stevenson -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
2
Indications for Use
510(k) Number (if known) K152400
Device Name General & Plastic Surgery Instruments
Indications for Use (Describe)
Manually operated minimally invasive General & Plastic Surgery Instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.
| 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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| 510(k) Summary | |||
|---|---|---|---|
| Date prepared: | September 17, 2015 | ||
| Applicant: | Sontec Instruments Inc. | ||
| Contact person: | Stefan M. Scanlan | ||
| Vice President | |||
| 7248 South Tucson Way | |||
| Centennial, Colorado 80112 | |||
| Phone: (303) 790-9411 | |||
| Fax: (303) 792-2606 | |||
| Email: sscanlan@sontecinstruments.com | |||
| Trade names: | General & Plastic Surgery Instruments | ||
| Common name: | Minimally Invasive Surgical Instruments | ||
| (Endoscope & Accessories) | Class: | II | |
| Classification name: | Endoscope & Accessories | Product code: | GCJ |
| Predicate device: | K120012; K110121; K945474; K925198 |
Device description:
Sontec Instruments are a family of manual, instruments consisting of Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors and Suction Tips. These reusable devices are packaged non-sterile and are steam sterilizable.
Indications for Use:
Sontec Instruments are manually operated instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, probing, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.
4
Technological characteristics: All components of the Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors and Suction Tips are comprised of materials which are in accordance with ISO 10993-1:2009. The contact time (