(29 days)
Not Found
No
The device description explicitly states it is a "non-powered stapling device" and there are no mentions of AI, ML, or image processing. The performance studies focus on mechanical aspects like staple form and safety mechanism.
No.
The device is a surgical stapler used to create anastomoses, which is a surgical tool rather than a therapeutic device designed to treat a disease or condition.
No
This device is a surgical stapler used for creating anastomoses, which is a therapeutic function rather than a diagnostic one. It physically joins tissues, resects tissue, and places staples, none of which are diagnostic actions.
No
The device description explicitly states it is a "hand-held, non-powered stapling device" and describes physical components like "titanium staples" and "shafts," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating anastomoses (surgical connections) in the alimentary tract during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical stapler that physically manipulates tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device is a surgical instrument used during a surgical procedure, not a diagnostic tool used on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The CQ ENCE Circular Staplers have application throughout the alimentary tract.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 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.
V. INDICATIONS FOR USE
4
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'ENCETM
Circular Stapler (Subject) | Predicate ReachTM Circular
Stapler
(K120179) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anatomical Site Used | Various soft tissues accessible during
laparoscopic procedures | Various soft tissues accessible
during laparoscopic procedures | Same |
| Product Models Provided | SeCQure CQ'ENCETM 1
CS34, CS31, CS28, CS25, CS25L,
CS21, CS21L
ReachTM 1
ACS34D, ACS31D, ACS28D,
ACS25D, ACS25DL, ACS21D
ACS21DL | RCS34D, RCS31G, RCS28G,
RCS25G, RCS23G,
RCS17G | Equivalent. The subject
device is provided in a
21mm size which is
within the previously
cleared range and was
cleared in K071023. The
17 mm size is
discontinued. The models
are available in two brand
types, ReachTM or
SeCQure CQ'ENCETM,
which are the same with
the 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-Range
Lockout | Firing Safety with Out-of-Range
Lockout | Same |
| Main Device
Features/Components | Anvil
Cartridge | Anvil
Cartridge | 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 Unalloyed
Titanium | Staples: ASTM F 67 Unalloyed
Titanium | Equivalent. A
biocompatible lubricant
was added to the
manufacturing process in
the current configuration. |
| | End Effector: polycarbonate and
stainless steel | End Effector: polycarbonate and
stainless 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 Staples
1.2 to 2.2 mm for 4.8 mm staples | 1.5 and 2.2 mm | Same staple height. The
Staple Height labeling has
been amended to align
with industry standard to
describe the range of
staple heights to be
selected by the user. The
staple height remains
adjustable in the control
of the user. |
| End Effector Diameters | 34mm, 31mm, 28mm, 25mm, and
21mm | 34mm, 31mm, 28mm, 25mm,
23mm and 17 mm | Equivalent. The subject
device is provided in a
21mm size which is
within the previously
cleared range. The 17 mm
size 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 duration
Staples are biocompatible for permanent implantation | Stapler is biocompatible for blood/bone/tissue contact for limited duration
Staples 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.
5
6
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.