The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.

AI/ML Overview

The Standard Clamp, Disposable is a laparoscopic surgical instrument designed to grasp, clamp, and manipulate soft tissues. The following information details the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Testing Category	Acceptance Criteria	Reported Device Performance
Reliability Testing	95% reliability at 90% confidence for performing 6 use cycles (opening and closure) and meeting requirements for trocar insertion, visual inspection, and functional performance for each cycle.	Testing completed without deviations. All samples met requirements for trocar insertion, visual inspection, and functional performance for each cycle. Zero failures were observed in simulated use cycles, demonstrating the ability to perform for its intended use, similar to the predicate device.
Tissue Compression	Clamping forces of the Standard Clamp, Disposable should be less than or equal to that of the reusable Standard Clamp (predicate device) when tested with excised porcine stomach.	Testing completed without deviations. Thirty (30) test runs demonstrated the Standard Clamp, Disposable compressed tissue with forces less than or equal to that of the Standard Clamp, Reusable.
Tissue Slippage	Tissue will not slip from the jaws when a working load (maximum load typically applied in surgical procedures) is applied, with 95% probability and 90% confidence, using excised porcine stomach.	Testing completed without deviations. Thirty (30) test runs demonstrated that tissue did not slip from the Standard Clamp, Disposable jaws when a working load was applied to the tissue, achieving 95% probability with 90% confidence. This demonstrates functionality substantially equivalent to the predicate device, reusable Standard Clamp.
Closure Strength	Closure mechanism must have a safety margin greater than or equivalent to 1.5, ensuring the worst-case stress on the closure system will not exceed the strength of the device closure system (jaws remain closed when placed in the closed position).	Testing completed without deviations. Ten (10) test runs demonstrated that the closure mechanism had a safety margin of 11.6, exceeding the required safety margin. This demonstrates that the closure system is functional for device use and substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Reliability Testing: The exact sample size for reliability testing is not explicitly stated, but the text mentions "All samples" and "zero failures" in "simulated use cycles."
Tissue Compression: 30 test runs.
Tissue Slippage: 30 test runs.
Closure Strength: 10 test runs.

The data provenance is retrospective bench testing conducted by Standard Bariatrics. The type of data appears to be primarily laboratory measurements and observations from simulated use conditions. The country of origin of the data is not specified, but the submission is from Standard Bariatrics in Cincinnati, Ohio, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The provided text does not mention the use of experts to establish ground truth for the bench tests. These tests appear to rely on objective mechanical measurements and observations against pre-defined performance metrics.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the testing involves objective measurements rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not provided." The study presented is bench testing comparing the proposed device to its predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these bench tests is based on objective performance metrics and established engineering principles. For example, force measurements, tissue slippage observations, and safety margin calculations. For tissue compression and slippage, excised porcine stomach was used as a biological model.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical surgical instrument, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 19, 2017

Standard Bariatrics Ms. Alison Sathe VP of Regulatory Affairs 4362 Glendale Milford Rd. Cincinnati, Ohio 45242

Re: K170379

Trade/Device Name: Disposable Standard Clamp Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 1, 2017 Received: February 7, 2017

Dear Ms. Sathe:

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 Actinclude 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,

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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) K170379

Device Name Standard Clamp, Disposable

Indications for Use (Describe)

The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.

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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Image /page/3/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD" and "BARIATRICS" in black, bold sans-serif font. The trademark symbol is located to the right of the word "BARIATRICS".

510(K) Summary

SUBMITTER l.

Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA

Phone: 513-30407971 Email: alison@standardbariatrics.com

Contact Person: Alison Sathe Date Prepared: Feb. 1, 2017

II. DEVICE

Name of Device: Standard Clamp, Disposable Common or Usual Name: Laparoscopic Surgical Instrument Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: GCJ

III. PREDICATE DEVICE

Standard Bariatrics Standard Clamp, K161720 This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.

VI. INTENDED USE

The Standard Clamp, Disposable is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. The Standard Clamp, Disposable is intended to

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Image /page/4/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized "S" inside, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The logo is clean and modern, with a focus on the company name.

be inserted into the peritoneal cavity through a 12mm trocar and used in up to six cycles of opening and closure to grasp, clamp and manipulate long, 1.2 to 4.5mm thick, planes of soft tissues such as the stomach. The Standard Clamp, Disposable is not intended for direct contact with the cardiovascular system, lymphatic system or cerebrospinal fluid. The Standard Clamp, Disposable can be used while a surgeon uses devices such as a stapler adjacent to tissue that is clamped with the Standard Clamp, Disposable, e.g., to help guide endoscopic staplers during resection of tissue such as in sleeve gastrectomy.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.

Product	Standard Clamp, Disposable(proposed)	Standard Clamp, Reusable(161720)
Disposable/Reusable	Disposable	Reusable
Materials	End Effector: aluminumShaft: stainless steelHandle: polycarbonate	End Effector: stainless steelShaft: stainless steelHandle: stainless steel
Overall Length	26.3 inches (66.8 cm)	25.4 inches (64.5 cm)
End Effector Length	10.6 inches (27 cm)	10.6 inches (27 cm)
End Effector Width	0.47 inches (12 mm)	0.47 inches (12 mm)
Shaft Width	0.39 inches (10 mm)	0.39 inches (10 mm)
Weight	0.5 lbs.	1.7 lbs.
Articulation	none	up to 55° from midline
End effector design	Aluminum jaws with non-piercing ridgesto grasp tissue	Stainless steel jaws with non-piercing ridgesto grasp tissue
End effector closure	Distal to proximal closure	Parallel closure
Handle	Pistol grip	Inline grip
Sterilization Method	Gamma Sterilization	Steam Sterilization
Anatomical Site Used	Various soft tissues accessible duringlaparoscopic procedures	Various soft tissues accessible duringlaparoscopic procedures
Types of procedures	Laparoscopic procedures	Laparoscopic procedures
Energy Delivered?	No	No
Compatible with 12mm trocar?	Yes	Yes
Biocompatibility	Biocompatible for blood/bone/tissuecontact for limited duration	Biocompatible for blood/bone/tissuecontact for limited duration
Packaging	Tyvek pouch in cardboard box	Plastic pouch in cardboard box

Table 1: Technological Characteristics

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Image /page/5/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD BARIATRICS" in black, sans-serif font. The "TM" symbol is located to the right of the word "BARIATRICS".

VIII. PERFORMANCE DA

Standard Clamp, Disposable performance bench testing was provided and demonstrated substantial equivalence to the predicate device. Clinical testing was not provided. Bench testing provided is described in Table 2.

Table 2: Bench Testing Summary

Testing	Purpose of Testing	Results	How Results Support
ReliabilityTesting	Standard Clamp, Disposabledevices were tested in simulateduse conditions to demonstratereliability of the device to perform6 use cycles (i.e. opening andclosure cycles) per the devicespecifications.	Testing was completed per theprotocol without deviations. Allsamples met the requirementsfor trocar insertion, visualinspection and functionalperformance for each cycle.Standard Clamp, Disposabledevices were cycled in simulateduse cycles with zero failures.	Substantial EquivalenceThe Standard Clamp,Disposable was tested to95% reliability at 90%confidence, demonstratingthe ability to perform for itsintended use, similar to thepredicate device.
TissueCompression	Standard Clamp, Disposabledevices were tested using excisedporcine stomach to compare theclamping forces of the StandardClamp, Disposable to the predicatedevice, reusable Standard Clamp.	Testing was completed per theprotocol without deviations.Thirty (30) test runsdemonstrated the StandardClamp, Disposable compressedtissue with forces less than orequal to that of the StandardClamp, Reusable.	Testing demonstrates thatthe clamping forces of theStandard Clamp, Disposableis less than or equal to thatof the reusable StandardClamp.
TissueSlippage	Standard Clamp, Disposabledevices were tested using excisedporcine stomach to verify that thetissue will not slip from the jawswhen a working load (i.e. amaximum load typically applied insurgical procedures) is applied tothe tissue.	Testing was completed per theprotocol without deviations.Thirty (30) test runsdemonstrated that tissue didnot slip from the StandardClamp, Disposable jaws when aworking load was applied to thetissue.	Testing demonstrates thattissue will not slip from thejaws of the Standard Clamp,Disposable 95% probabilitywith 90% confidence. Thisdemonstrates functionalitysubstantially equivalent tothe predicate device,reusable Standard Clamp.
ClosureStrength	Standard Clamp, Disposabledevices were tested to ensure theclosure mechanism has a safetymargin greater than or equivalentto 1.5. A safety margin of 1.5ensures that the worst-case stresson the closure system will notexceed the strength of the deviceclosure system (i.e. the devicejaws will remain closed whenplaced in the closed position).	Testing was completed per theprotocol without deviations. Ten(10)) test runs demonstratedthat the closure mechanismdemonstrated a safety margin of11.6, exceeding the requiredsafety margin	Testing demonstrates thatthe Standard Clamp,Disposable closure system isfunctional for device use.Testing demonstrates thatthe Standard Clamp,Disposable closuremechanism is substantiallyequivalent to that of thepredicate.

CONCLUSIONS

The Standard Clamp, Disposable has the same indications, technological characteristics, principles of operation as its predicate device. There are no new issues of safety or effectiveness. Standard Clamp, Disposable is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.