General & Plastic Surgery Instruments

K152400 · Sontec Instruments, Inc. · GCJ · Jan 22, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K152400
• Device Name: General & Plastic Surgery Instruments
• Applicant: Sontec Instruments, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Sontec Instruments are a family of manual, reusable surgical tools including clamps, forceps, knot tiers, needle holders, knot pushers, scissors, and suction tips. These devices are used by surgeons in clinical settings (OR) to perform mechanical surgical tasks such as tissue manipulation, cutting, and suturing. The instruments are provided non-sterile and require steam sterilization by the user before use. They function purely through manual operation by the clinician; no electronic or automated components are involved. The devices facilitate surgical procedures by providing the necessary mechanical interface for tissue interaction, thereby assisting in the completion of general and plastic surgery interventions.

Clinical Evidence

No clinical data. Bench testing only, consisting of validation of cleaning, thermal disinfection, and steam sterilization processes for reusable handheld surgical instruments.

Technological Characteristics

Manual surgical instruments constructed from stainless steel (ISO 7153-1/ASTM F899, ISO 15510/ASTM A276/A564/A484), titanium (ISO 5432/ASTM F136/B265), aluminum 5052 (MIL 8625), and tungsten carbide. Materials comply with ISO 10993-1:2009 for tissue/bone contact <24 hours. Steam sterilizable per ANSI/AAMI ST79; cleaning per ASTM A380 and ASTM F1744.

Indications for Use

Indicated for patients undergoing open, mini-open, or endoscopic surgical procedures (e.g., thoracoscopy, laparoscopy) requiring aspiration, clamping, cutting, dissection, drainage, grasping, ligation, probing, or suturing.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K120012
• K110121
• K945474
• K925198

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: ;"> </span> 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<br>Vice President<br>7248 South Tucson Way<br>Centennial, Colorado 80112<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Trade names: | General & Plastic Surgery Instruments | | |
| Common name: | Minimally Invasive Surgical Instruments<br>(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 compositions<br>MAX (mass/mass %) |
|----------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Stainless<br>Steel<br>(e.g.17-<br>4/304/420) | ISO 7153-1/<br>ASTM F899<br><br>ISO 15510/<br>ASTM A276/<br>ASTM A564/<br>ASTM A484 | C .08, Mn 2.0, Si 1.0, S<br>.03 P.045, Cr 15-20, Ni<br>3-11, Cu 3-5 |
| Titanium | ISO<br>5432/ASTMF136/ASTMB265 | N .05 C .08 H .012 Fe<br>.25 O .13 Al 5.5-6.5 Va<br>3.5-4.5 Ti Balance |
| Aluminum<br>5052 | MIL 8625 | Si .25, Fe .4, Cu, .1, Mn .1,<br>Mg 2.2-2.8, Cr .15-.35, Z<br>.1, Other .15, Al remainder |
| Tungsten<br>Carbide G4 | N/A | TC 87%, Co12%, TA/NbC<br>1% |

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 tests<br>submitted or relied upon: | Cleaning, Thermal Disinfection and Steam Sterilization<br>Validations of Subject Reusable Hand Held Surgical<br>Instruments |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical tests submitted<br>or relied upon: | None |
| Substantial equivalence<br>conclusion: | The Sontec General & Plastic Surgery Instruments are<br>substantially equivalent to the legally marketed FDA cleared<br>predicate devices, based on intended use, design, material,<br>chemical composition, and energy source. The proposed<br>devices do not introduce new issues of safety or<br>effectiveness. |