(505 days)
Not Found
No
The summary describes a mechanical stapling device and does not mention any AI or ML components or functionalities.
No
The device is a surgical stapler used for creating anastomoses (connections between organs) but does not provide therapy for a disease or condition. Instead, it facilitates a surgical procedure.
No
Explanation: The device is a surgical stapler used to create anastomoses, which is a therapeutic function, not a diagnostic one. It resects tissue and places staples rather than detecting or identifying a medical condition.
No
The device description clearly describes a physical surgical stapler that places titanium staples and resects tissue with a knife blade. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical stapler used for creating anastomoses within the alimentary tract. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a mechanical device that places staples and resects tissue. This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention.
N/A
Intended Use / Indications for Use
The REACH™ RCS Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The REACH™ RCS Circular Stapler is a single patient use device which places a double staggered row of titanium staples. During staple formation, the instrument knife blade resects the excess tissue, creating a circular anastomosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open and laparoscopic surgeries (implicitly, medical professionals in a surgical setting)
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)
The REACH™ RCS Circular Stapler's performances is identical to those described in 510(k) K024275
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
CHAPTER 5. SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness for REACH™ RCS Circular Stapler is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 878.4750
| Applicant: | Reach Surgical, Inc |
|---|---|
| Address: | Changping District, 29 Life Science Park Road, B-211, Beijing, |
| China 102206 | |
| Contact Person: | Richard Fang |
| Telephone: | (86-10)-82894884 |
| Email: | yrfang@gmail.com |
| Date of Preparation: | April 8, 2007 |
| Device Name: | REACH™ RCS Circular Stapler |
| Classification Name: | Staple, Implantable |
| Device Class: | Class II |
| Product Code: | GDW |
| Classification Panel | General & Plastic Surgery |
| Type of submission | Traditional 510K |
Table 5-1 General Information
Intended use:
The REACH™ RCS Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Indications for Use:
The REACH™ RCS Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Device Description
The REACH™ RCS Circular Stapler is a single patient use device which places a double staggered row of titanium staples. During staple formation, the instrument knife blade resects the excess tissue, creating a circular anastomosis.
All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) K024275
1
Substantial Equivalence Information:
Predicate Device: Auto Suture PREMIUM PLUS CEEA Disposable Stapler by United States Surgical, 510(k) K024275.
Technological Characteristics:
The REACH™ RCS Circular Stapler's technological and safety characteristics are identical to those described in 510(k) K024275
Performance Data:
The REACH™ RCS Circular Stapler's performances is identical to those described in 510(k) K024275
Conclusion:
The data submitted in this 510(K) Premarket Notification supports the finding that this product is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed predicate device. Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
AUG 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reach Surgical, Inc. % Mr. Richard Fang 4480 Lake Forest Drive, Suite 414 Cincinnati, Ohio 45242
Re: K071023
Trade/Device Name: REACH™ RCS Circular Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: July 21, 2008 Received: July 22, 2008
Dear Mr. Fang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Richard Fang
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your levice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mulhern
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
23
INDICATIONS FOR USE CHAPTER 4.
510(k) Number (if known):
Device Name: REACH™ RCS Circular Stapler
Indications for Use:
The REACH™ RCS Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mulkerss
(Division Sign-Off) (Division Sign-Only Division of Neurological Devices
510(k) Number_