The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.

Device Description

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 stomach. 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

This document describes a 510(k) premarket notification for the "Standard Clamp, Disposable". This application asserts substantial equivalence to a predicate device, K170379, also named "Standard Clamp, Disposable". The core argument for substantial equivalence relies on the subject device having identical technological characteristics to the predicate and the performance data for the predicate device still being applicable.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria in measurable terms (e.g., a specific percentage of reduction in staple cartridges, a maximum adverse event rate). Instead, it discusses the study's findings qualitatively.

Acceptance Criteria (Explicitly stated in doc)	Reported Device Performance (from study)
Not explicitly stated as pass/fail criteria. The study aimed to evaluate the number of staple cartridges used and safety.	Safety: "no significant difference in post-operative adverse event rate (9.5% vs. 5.6%, p = NS)" between Standard Clamp and no clamp group.
	Adverse Events (Standard Clamp group): No readmission or additional intervention required. One patient seen for syncope unrelated to procedure.
	Adverse Events (No Clamp group): One patient admitted for IV hydration due to persistent nausea/emesis.
	Serious Adverse Events (Both groups): "no occurrences of postoperative leak, bleeding, or stricture formation noted in either group."
	Effect on Staple Cartridges: The document states the study "evaluated the number of staple cartridges used" but does not report specific performance data or a comparison result regarding staple cartridge usage. It implicitly suggests the clamp's use is safe and guides staplers, but the direct outcome on cartridge quantity isn't quantified here.

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

Test Set Sample Size: 30 subjects
Data Provenance: Prospective, single-center, randomized controlled study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting U.S. or internationally applicable clinical trial standards. The study was performed independently of Standard Bariatrics.

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

This information is not provided in the document. The study involves surgical procedures and post-operative follow-up, implying medical professionals were involved in assessing outcomes, but the specific number and qualifications of experts establishing ground truth (e.g., for adverse events) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not done. The study described is a clinical study comparing the use of the device (Standard Clamp) against a control (no clamp) in a surgical setting. It does not involve human readers interpreting data.

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

Not applicable. This device is a physical surgical instrument, not an algorithm or AI system. Therefore, the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

The ground truth used was clinical outcomes data (e.g., post-operative adverse event rates, readmissions, interventions, specific complications like leak, bleeding, stricture formation). This would have been established through direct clinical observation, patient records, and follow-up examinations by medical professionals.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm that requires a training set. The performance testing relies on engineering bench tests and a clinical study.

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

Not applicable. As stated above, there is no training set for this type of device.

Summary

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September 27, 2018

Standard Bariatrics Alison Sathe Regulatory 4362 Glendale Milford Rd. Cincinnati, Ohio 45242

Re: K181608

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: September 5, 2018 Received: September 5, 2018

Dear Alison 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical on-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, bold font. The text is arranged vertically, with "Jennifer R." on the top line and "Stevenson -S3" on the second line. The background of the image is a light blue color.

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) K181608

Device Name Standard Clamp, Disposable

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

I. SUBMITTER

Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA

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

Contact Person: Alison Sathe Date Prepared: June 15, 2018

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, Disposable K170379 This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

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 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

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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 staplers during resection of tissue such as in sleeve gastrectorny.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Standard Clamp, Disposable has the exact same technological characteristics as the predicate device.

Product	Predicate Standard Clamp, Disposable (K170379)	Standard Clamp, Disposable (Subject)
Disposable/Reusable	Disposable	Same
Materials	End Effector: aluminumShaft: stainless steelHandle: polycarbonate	Same
Overall Length	26.3 inches (66.8 cm)	Same
End Effector Length	10.6 inches (27 cm)	Same
End Effector Width	0.47 inches (12 mm)	Same
Shaft Width	0.39 inches (10 mm)	Same
Weight	0.5 lbs.	Same
Articulation	none	Same
End effector design	Aluminum jaws with non-piercingridges to grasp tissue	Same
End effector closure	Distal to proximal closure	Same
Handle	Pistol grip	Same
Sterilization Method	Gamma Sterilization	Same
Anatomical Site Used	Various soft tissues accessible duringlaparoscopic procedures	Same
Types of procedures	Laparoscopic procedures	Same
Energy Delivered?	No	Same
Compatible with 12 mm trocar?	Yes	Same
Biocompatibility	Biocompatible for blood/bone/tissuecontact for limited duration	Same
Packaging	Tyvek pouch in cardboard box	Same

Table 1: Technological Characteristics

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VIII. PERFORMANCE D.

Standard Clamp, Disposable performance bench testing was provided in K170379 and remains unchanged. Clinical data is provided in Section 020 of this submission. The data provided is a prospective, single-center, randomized controlled study performed independently of Standard Bariatrics including 30 subjects undergoing sleeve gastrectomy procedures. The study evaluated the number of staple cartridges used during cases with the Standard Clamp compared to those performed without the Standard Clamp. In addition to this quality metric, safety data was collected on all subjects.

After three-month follow-up, comparison of Standard Clamp to no clamp group revealed no significant difference in post-operative adverse event rate (9.5% vs. 5.6%, p = NS). No patients in the Standard clamp group required readmission or additional intervention. One patient was seen in the emergency department for syncope determined to be cardiac in nature and unrelated to the prior procedure. In the no clamp group, one patient was admitted approximately 1 week following surgery for intravenous hydration due to persistent nausea and emesis. Overall, there were no occurrences of postoperative leak, bleeding. or stricture formation noted in either group. The study demonstrates the safe use of the Standard Clamp in sleeve gastrectomy per its intended use.

IX. CONCLUSIONS

The Standard Clamp, Disposable has the same intended use, technological characteristics, and 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.