This product is intended to pass suture through soft tissue lavers (fascia, muscle and perioneum) of a trocar wound at the end of laparoscopic surgery.

It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.

Device Description

The CrossBow Fascial Closure System is a set of single-use instruments primarily intended for the use of closing soft tissue layers (fascia, muscle and peritoneum) of a trocar wound following laparoscopic surgery. The CrossBow Fascial Closure System has two basic components: (1) a suture passer component used to pass suture through the abdominal wall, and (2) a guide used to repeatedly direct the needle through the abdominal wall using visual markers to reference the needle puncture location off the inner wall of the abdomen. The guide has two deployable snare loops used to secure and retrieve the free ends of suture passed by the suture passer. The device also has an accessory adaptor to accommodate larger size port defects.

AI/ML Overview

The provided document describes the CrossBow Fascial Closure System and its substantial equivalence determination. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Validation and/or Verification Method	Acceptance Value/Criteria	Verification and Validation Results
Mechanical Testing (Needle Penetration)	To require comparable or less penetration force than competitive devices	Acceptable
Mechanical Testing (Snare Loop Integrity)	To exceed the strength of the expected loading requirements	Acceptable
Mechanical Testing (Needle Security in Passer)	To exceed the strength of the expected loading requirements	Acceptable
Mechanical Testing (Guide Suture Security)	To exceed the strength of the expected loading requirements	Acceptable
Mechanical Testing (Targeting & No. of Uses)	To provide accurate performance and expected number of uses	Acceptable
Surgeon Validation Lab (Animal model)	Successful placement of suture and closure of defect	Acceptable

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each mechanical test. However, it indicates a "Surgeon Validation Lab (Animal model)" was performed as part of the non-clinical performance data. The exact number of animals or trials within this model is not stated. The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. No specific country of origin for data or whether it was retrospective/prospective is mentioned, but typically such validation studies are prospective for regulatory submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document mentions "Surgeon Validation Lab (Animal model)" and that the device is "to be used only by surgeons trained in endoscopic/laparoscopic surgery." This indirectly suggests that surgeons were involved in validating the device, but it does not state the number of experts nor their specific qualifications (e.g., years of experience, board certification) for establishing ground truth in the animal model.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set results. The acceptance criteria for the mechanical tests are objective (e.g., "to exceed the strength," "to require comparable or less penetration force"), and the animal model criterion is "Successful placement of suture and closure of defect," which would likely be a direct observation by the participating surgeons.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve "human readers" or AI assistance in the way described. The comparative effectiveness assessment was against a predicate device (Weck EFx Fascial Closure System, K132362) based on mechanical and performance testing.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This does not apply. The CrossBow Fascial Closure System is a physical surgical instrument, not an algorithm, and inherently requires human-in-the-loop performance (i.e., a surgeon). Standalone performance would refer to the device's mechanical integrity as tested, which was indeed evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical tests, the ground truth was based on objective measurements against defined criteria (e.g., strength, force, accuracy, number of uses). For the "Surgeon Validation Lab (Animal model)," the ground truth was direct observation and assessment of the successful placement of suture and closure of defect, likely by the surgeons performing the procedure in the lab. This could be considered a form of expert assessment based on procedural success.

8. The sample size for the training set

This information is not applicable as this is a physical medical device and not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable as this is a physical medical device and not an AI or machine learning algorithm that requires a "training set."

Summary

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December 1, 2017

SutureEase, Inc. Mr. Scott Heneveld Chief Operating Officer 1735 N First Street, Suite 300 San Jose, California 95112

Re: K172666

Trade/Device Name: CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW, HCF Dated: August 28, 2017 Received: September 5, 2017

Dear Mr. Heneveld:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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,

David Krause -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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

1 of 1

510(k) Number (if known)

Device Name CrossBow Fascial Closure System

Indications for Use (Describe)

This product is intended to pass suture through soft tissue lavers (fascia, muscle and perioneum) of a trocar wound at the end of laparoscopic surgery.

It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.

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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Traditional 510(k) Premarket Notification CrossBow Fascial Closure System

1. 510K SUMMARY

Manufacturer	Contact Person
Suture Ease, Inc.	Scott Heneveld
1735 N First Street, Suite 300	COO
San Jose, California 95112	(408) 459-7595

Trade Name: CrossBow Fascial Closure System Common / Usual Name: Endoscopic tissue approximation device Classification Name: Endoscope and Accessories Regulation Number: 21 CFR 876.1500 Device Class: II Product Code: HCF, OCW Predicate Device: Weck EFx Fascial Closure System, K132362

Device Description

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Traditional 510(k) Premarket Notification CrossBow Fascial Closure System

Intended Use / Indications

1.1 Intended Use:
The device is intended to provide the function of aiding in the closure of the fascia/peritoneum at the trocar sites at the end of a laparoscopic procedure.
1.2 Indication for Use:
- 1.2.1 This product is intended to pass suture through soft tissue layers (fascia. muscle and peritoneum) of a trocar wound at the end of laparoscopic surgery.
- 1.2.2 It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.
1.3 Contra-Indications:

The device is subject to the following contra-indications:

1.3.1 This device is not intended for use where endoscopic techniques are contraindicated.
1.3.2 Do NOT use the CrossBow device where it is not possible to visualize the tip of the needle during insertion or removal.
1.3.3 The device is not intended for use when the minimum tissue thickness does not reach the markings on the guide component.

Summary of Non-Clinical Performance Data

The following non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices;

Validation and/orVerification Method	Acceptance Value/Criteria	Verification andValidation Results
Mechanical Testing(Needle Penetration)	To require comparable or less penetrationforce than competitive devices	Acceptable
Mechanical Testing(Snare Loop Integrity)	To exceed the strength of the expectedloading requirements	Acceptable
Mechanical Testing(Needle Security in Passer)	To exceed the strength of the expectedloading requirements	Acceptable
Mechanical Testing(Guide Suture Security)	To exceed the strength of the expectedloading requirements	Acceptable
Mechanical Testing(Targeting & No. of Uses)	To provide accurate performance andexpected number of uses	Acceptable
Surgeon Validation Lab(Animal model)	Successful placement of suture andclosure of defect	Acceptable

The CrossBow Fascial Closure System tested met the predetermined acceptance criteria. Based on the results of the testing, the CrossBow Fascial Closure System is safe and effective for its intended use.

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Traditional 510(k) Premarket Notification CrossBow Fascial Closure System

Biocompatibility

The biocompatibility evaluation for the CrossBow Fascial Closure System was conducted in accordance with the International Standard ISO 10993-1: "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA.

Biomaterial testing was performed on the device components individually and the following tests were conducted on the finished, completed device after gamma sterilization:

Cytotoxicity ●
Irritation ●
Sensitization .
Material Mediated Pyrogenicity ●
Hemocompatibility

According to ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" the CrossBow Fascial Closure System is categorized as:

Externally Communicating
. Blood Contacting
Less than 24 hours

Conclusion

The CrossBow Fascial Closure System is substantially equivalent in intended use and fundamental scientific technology as the Weck EFx Endo Fascial Closure System (K132362). The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.

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.