(150 days)
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.
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.
This document is a 510(k) premarket notification from the FDA, which determines substantial equivalence for medical devices. It does not contain information about the acceptance criteria or a study proving device performance in the way requested for an AI/CADe device.
The requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training data) is typically found in performance studies for diagnostic or AI/CADe devices, which this document is not describing.
This 510(k) document is for "General & Plastic Surgery Instruments," which are manual surgical tools like clamps, forceps, and scissors. The substantial equivalence is based on their intended use, design, material, chemical composition, and energy source compared to existing predicate devices.
Therefore, I cannot provide the requested table and study information because this document does not pertain to an AI/CADe device or a study demonstrating diagnostic performance.
Instead, the document focuses on:
- Device Description: Manual, reusable surgical instruments (Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors, Suction Tips).
- Indications for Use: Performing specific functions (aspirating, clamping, cutting, dissecting, draining, grasping, ligating, probing, or suturing) during open, mini-open, or endoscopic surgical procedures.
- Technological Characteristics: Materials used (Stainless Steel, Titanium, Aluminum 5052, Tungsten Carbide G4) and their conformance to ISO/ASTM standards; cleaning and sterilization procedures (ASTM A380, ASTM F1744, ANSI/AAMI ST79).
- Non-clinical tests: Cleaning, Thermal Disinfection and Steam Sterilization Validations.
- Clinical tests: None (as explicitly stated).
- Substantial Equivalence: Concluded based on intended use, design, material, chemical composition, and energy source being similar to predicate devices, and not introducing new issues of safety or effectiveness.
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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
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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
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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. ScanlanVice President7248 South Tucson WayCentennial, Colorado 80112Phone: (303) 790-9411Fax: (303) 792-2606Email: 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.
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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 (<24 Hrs.) and type of contact (External Communicating Devices: Tissue, Bone, Dentin).
| Material | Material Designation | Chemical compositionsMAX (mass/mass %) |
|---|---|---|
| StainlessSteel(e.g.17-4/304/420) | ISO 7153-1/ASTM F899ISO 15510/ASTM A276/ASTM A564/ASTM A484 | C .08, Mn 2.0, Si 1.0, S.03 P.045, Cr 15-20, Ni3-11, Cu 3-5 |
| Titanium | ISO5432/ASTMF136/ASTMB265 | N .05 C .08 H .012 Fe.25 O .13 Al 5.5-6.5 Va3.5-4.5 Ti Balance |
| Aluminum5052 | MIL 8625 | Si .25, Fe .4, Cu, .1, Mn .1,Mg 2.2-2.8, Cr .15-.35, Z.1, Other .15, Al remainder |
| TungstenCarbide G4 | N/A | TC 87%, Co12%, TA/NbC1% |
Cleaning Metallic Medical Instruments is conducted per ASTM A380 post manufacturing to ensure that materials are free from machining oils.
The products will be provided clean, non-sterile, and intended to be reused and the cleaning and sterilizations were carried out in accordance with ASTM F1744 and ANSI/AAMI ST79.
The packaged device will withstand normal shipping and storage environments and labeling shall meet 21CFR 801, EN 1041, and ISO 15223.
| Non-clinical testssubmitted or relied upon: | Cleaning, Thermal Disinfection and Steam SterilizationValidations of Subject Reusable Hand Held SurgicalInstruments |
|---|---|
| Clinical tests submittedor relied upon: | None |
| Substantial equivalenceconclusion: | The Sontec General & Plastic Surgery Instruments aresubstantially equivalent to the legally marketed FDA clearedpredicate devices, based on intended use, design, material,chemical composition, and energy source. The proposeddevices do not introduce new issues of safety oreffectiveness. |
§ 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.