The CQ ENCE Circular Staplers have application throughout the alimentary tract for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries.

Device Description

The REACH™ and SeCQure CO'ENCE™ Circular Staplers (CO'ENCE™ Circular Staplers) are sterile, single-use, hand-held, non-powered stapling devices used during general surgical procedures for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries. The Circular Staplers place a double-staggered, circular row of titanium staples while simultaneously resecting tissue when the device is manually activated. The device is provided in five head diameter sizes: 34mm, 31mm, 28mm, 25mm, and 21mm (product codes CS34, CS31, CS28, CS25, and CS21 respectively). Each size device can be purchased with a standard 27cm length shaft. The CS21 and SC25 can also be purchased with a longer, 35cm shaft (product codes CS21L, CS25L) to facilitate surgeon access to desired tissues. The CQ 'ENCE™ Circular Stapler allows the surgeon to control tissue compression by varying the closed staple height. The CQ ENCE Circular Stapler forms traditional B-shaped staples that are comprised of titanium. Safe removal of the device is facilitated by opening the instrument one full the Audible Indicator makes a clicking sound.

AI/ML Overview

The provided document is a 510(k) summary for the Reach™ and CQ'ENCE™ Circular Staplers, seeking to demonstrate their substantial equivalence (SE) to a predicate device. The document primarily focuses on establishing SE based on comparison of technological characteristics and performance bench testing, rather than a clinical study with human subjects for efficacy or diagnostic performance. Therefore, many of the typical elements of an AI/ML device study (like MRMC studies, expert adjudication for ground truth of an imaging dataset, training set details) are not applicable or described in this document.

However, based on the information provided, here's an attempt to extract and interpret the relevant details regarding acceptance criteria and performance, as they relate to the mechanical device testing presented:

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria (Specification)	Reported Device Performance (Result)
Visual Inspection	Meets specifications (Implied: visually acceptable, free from defects)
Dimensional Analysis	Meets specifications (Implied: dimensions are within acceptable tolerances)
Staple Form	Meets specifications (Implied: staples consistently form the specified "B" shape with correct height)
Safety Mechanism Performance	Meets specifications (Implied: Firing Safety with Out-of-Range Lockout functions as intended)
Functional Equivalence (e.g., creation of anastomoses, tissue resection)	Demonstrated through bench testing to same specifications as predicate. (Specific quantitative metrics not detailed but implied to meet functional requirements.)
Sterilization Assurance Level (SAL)	10^-6
Endotoxin Limit	0.5 EU/mL (20 EU/Device)
Biocompatibility	Stapler: limited duration blood/bone/tissue contact; Staples: permanent implantation
Shelf Life	5 years

Study Details (Bench Testing):

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states "Reach™ Circular Stapler performance bench testing was provided in K120179. Testing for the Reach™ and CQ 'ENCE™ Circular Stapler is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Reach™ Circular Stapler previously provided in K120179." It does not specify the exact number of devices or test repetitions used for the bench testing.
- Data Provenance: The testing was conducted as part of the submission process, presumably by the manufacturer (Reach Surgical, Inc. / SeCQure Surgical). The location of the testing is not explicitly stated, but the company is based in China with a US contact. This would be considered prospective internal testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. This is a mechanical device, and the "ground truth" is established by engineering specifications, physical measurements, and functional performance tests (e.g., measuring staple form, activation of safety mechanisms). "Experts" in the sense of radiologists interpreting images are not involved.
Adjudication Method for the Test Set:
- Not Applicable. As this is mechanical testing against engineering specifications, there is no need for human adjudication of subjective interpretations. Measurements and functional checks are performed against defined criteria.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This document describes a surgical stapler, a mechanical device.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML algorithm. The performance of the stapler itself is the focus, without an "algorithm-only" or "human-in-the-loop" distinction typical of AI medical devices. The device's operation is purely mechanical, and performance relates directly to its physical characteristics and activation.
The Type of Ground Truth Used:
- The "ground truth" for this medical device is based on engineering specifications, design requirements, and established functional performance metrics for surgical staplers. This includes parameters like staple formation, dimensions, safety mechanism activation, material properties (biocompatibility, endotoxin limits), and sterilization effectiveness.
The Sample Size for the Training Set:
- Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."
How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one.

Summary of the Study Proving Acceptance Criteria were Met:

The study proving the device meets the acceptance criteria was primarily a performance bench testing program. The document explicitly states:

"Performance bench testing was provided in K120179 [for the predicate device]."
"Testing for the Reach™ and CQ 'ENCE™ Circular Stapler is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Reach™ Circular Stapler previously provided in K120179."
"The data demonstrates that the Reach™ and CQ ENCE™ Circular Stapler meets the same specifications for visual inspection, dimensional analysis, staple form and safety mechanism performance."

This indicates that the manufacturer conducted a series of laboratory tests to assure that the new device's physical characteristics and functional performance matched those of the predicate device and met predefined engineering and quality specifications. The comparison table of technological characteristics further supports the demonstration of substantial equivalence by highlighting design similarities and explaining minor differences.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2019

Reach Surgical, Inc. % Rich Grant Official Correspondent SeCQure Surgical 4480 Lake Forest Dr. Cincinnati. Ohio 45242

Re: K192566

Trade/Device Name: Reach and CQ'ENCE Circular Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: September 6, 2019 Received: September 18, 2019

Dear Rich Grant:

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/cfdocs/cfpmn/pmn.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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192566

Device Name CQ'ENCE TM Circular Staplers

Indications for Use (Describe)

The CQ ENCE Circular Staplers have application throughout the alimentary tract for the creation of end-to-end, side-toside and end-to-side anastomoses in both open and laparoscopic surgeries.

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

I. SUBMITTER

Rach Surgical Inc. 120 Xinxing Road West Zone, TEDA Tianjin, Tianjin CHINA 300462

Contact Person: Richard Grant Phone: 513-608-4017 Email: rgrant@secquresurgical.com

Date Prepared: September 6, 2019

II. DEVICE

Name of Device: Reach™ and CQ ENCE™ Circular Stapler Common or Usual Name: Circular Stapler Classification Name: Staple, implantable (21 CFR 878.4750) Regulatory Class: II Product Code: GDW

III. PREDICATE DEVICE

REACHTM Circular Staplers, (K120179)

IV. DEVICE DESCRIPTION

The Circular Staplers place a double-staggered, circular row of titanium staples while simultaneously resecting tissue when the device is manually activated. The device is provided in five head diameter sizes: 34mm, 31mm, 28mm, 25mm, and 21mm (product codes CS34, CS31, CS28, CS25, and CS21 respectively). Each size device can be purchased with a standard 27cm length shaft. The CS21 and SC25 can also be purchased with a longer, 35cm shaft (product codes CS21L, CS25L) to facilitate surgeon access to desired tissues.

The CQ 'ENCE™ Circular Stapler allows the surgeon to control tissue compression by varying the closed staple height. The CQ ENCE Circular Stapler forms traditional B-shaped staples that are comprised of titanium. Safe removal of the device is facilitated by opening the instrument one full the Audible Indicator makes a clicking sound.

V. INDICATIONS FOR USE

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The CQ ENCE Circular Staplers have application throughout the alimentary tract for the creation of endto-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Reach™ and CQ 'ENCE™ Circular Stapler has the same technological characteristics as the predicate device with the exception of an additional device size and minor technological characteristics as described below

Product	Reach TM and SeCQure CQ'ENCETMCircular Stapler (Subject)	Predicate ReachTM CircularStapler(K120179)	Comparison
Anatomical Site Used	Various soft tissues accessible duringlaparoscopic procedures	Various soft tissues accessibleduring laparoscopic procedures	Same
Product Models Provided	SeCQure CQ'ENCETM 1CS34, CS31, CS28, CS25, CS25L,CS21, CS21LReachTM 1ACS34D, ACS31D, ACS28D,ACS25D, ACS25DL, ACS21DACS21DL	RCS34D, RCS31G, RCS28G,RCS25G, RCS23G,RCS17G	Equivalent. The subjectdevice is provided in a21mm size which iswithin the previouslycleared range and wascleared in K071023. The17 mm size isdiscontinued. The modelsare available in two brandtypes, ReachTM orSeCQure CQ'ENCETM,which are the same withthe exception of branding.
Cutting Mechanism	Circular Knife	Circular Knife	Same
Method of Activation	Single Trigger manually activated	Single Trigger manually activated	Same
Disposable/Reusable	Disposable	Disposable	Same
Safety Mechanism	Firing Safety with Out-of-RangeLockout	Firing Safety with Out-of-RangeLockout	Same
Main DeviceFeatures/Components	AnvilCartridge	AnvilCartridge	Same
	Instrument Shaft	Instrument Shaft
	Trigger	Trigger
	Safety Release	Safety Release
	Wing Nut	Wing Nut
	Staple Height Indicator	Staple Height Indicator
	Ancillary Trocar	Ancillary Trocar
	Shaft	Shaft
	Staple	Staple
Materials	Staples: ASTM F 67 UnalloyedTitanium	Staples: ASTM F 67 UnalloyedTitanium	Equivalent. Abiocompatible lubricantwas added to themanufacturing process inthe current configuration.
	End Effector: polycarbonate andstainless steel	End Effector: polycarbonate andstainless steel
	Shaft: stainless steel	Shaft: stainless steel
	Handle: polycarbonate	Handle: polycarbonate
	Lubricant: PTFE & Silicone Grease	Lubricant: Silicone Grease
Staple Shape	Standard "B" shaped staple	Standard "B" shaped staple	Same
Staple Height (open)	3.5 and 4.8 mm	3.5 and 4.8 mm	Same
Staple Height (closed)	1.0 to 1.8 for 3.5 mm Staples1.2 to 2.2 mm for 4.8 mm staples	1.5 and 2.2 mm	Same staple height. TheStaple Height labeling hasbeen amended to alignwith industry standard todescribe the range ofstaple heights to beselected by the user. Thestaple height remainsadjustable in the controlof the user.
End Effector Diameters	34mm, 31mm, 28mm, 25mm, and21mm	34mm, 31mm, 28mm, 25mm,23mm and 17 mm	Equivalent. The subjectdevice is provided in a21mm size which iswithin the previouslycleared range. The 17 mmsize is being discontinued.
Shaft Length	Standard (27cm), Long (35 cm)	Standard (27cm), Long (35 cm)	Same
Markings on Handle	Printed instructions for opening	None	Equivalent. Printed instructions were added for ease of use.
Anvil Tilt	Anvil Tilt Feature not offered	Anvil Tilt Feature offered	Equivalent. The Anvil Tilt feature is no longer offered as non-tilting is a standard for circular staplers.
Opening Method	Turn the Wing Nut counterclockwise one half to a full turn until the Audible Indicator clicks	Turn the Wing Nut counterclockwise one half to a full turn	Equivalent. Opening is the same. An audible click has been added to indicate to the user when the device is fully open.
Biocompatibility	Stapler is biocompatible for blood/bone/tissue contact for limited durationStaples are biocompatible for permanent implantation	Stapler is biocompatible for blood/bone/tissue contact for limited durationStaples are biocompatible for permanent implantation	Same
Endotoxin Limit	0.5 EU/mL (20 EU/Device)	0.5 EU/mL (20 EU/Device)	Same
Sterilization Method	EtO, SAL 10-6	EtO. SAL 10-6	Same
Packaging	Tyvek covered tray in cardboard box	Tyvek covered tray in cardboard box	Same
Shelf Life	5 years	5 years	Same

Table 1: Technological Characteristics

4 Note: The Reach and SeCQure CQ ENCE™ products are the same products with different branding i.e. the CS34 is the 34mm size SeCQure branded CQ ENCE™ Stapler and the ACS34D is the 34mm size Reach™ branded CQ ENCE™ Stapler. The devices are the same other than the branding on the labels and pad printed branding on the handles.

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PERFORMANCE DATA VII.

Reach™ Circular Stapler performance bench testing was provided in K120179. Testing for the Reach™ and CQ 'ENCE™ Circular Stapler is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Reach™ Circular Stapler previously provided in K120179. The data demonstrates that the Reach™ and CQ ENCE™ Circular Stapler meets the same specifications for visual inspection, dimensional analysis, staple form and safety mechanism performance. The materials used in the device, packaging, and sterilization method remain unchanged.

VIII. CONCLUSIONS

The CQ 'ENCE™ Circular Stapler has the same intended use and principles of operation as its predicate device. The minor differences in technological characteristics do not change the device use or application and have been tested to the same standards as the currently marketed devices. There are no new issues of safety or effectiveness. The CQ ENCE™ Circular Stapler is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.