(49 days)
Not Found
No
The summary describes a mechanical surgical stapler and does not mention any AI/ML components or functionalities.
Yes
The device is described as performing "surgical treatment of hemorrhoidal disease," which is a therapeutic intervention.
No
Explanation: The device description indicates that it is a surgical stapler used for treatment, not for diagnosis.
No
The device description clearly describes a physical surgical stapler and accessories, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform surgical treatment of hemorrhoidal disease throughout the anal canal. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical stapler used for tissue manipulation and treatment within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these specimens.
Therefore, the PROXIMATE® HCS Hemorrhoidal Circular Stapler is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories is available in a 33 mm diameter size only. The instruments allow the surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed to facilitate insertion, operation and removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal canal
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)
Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in pressure holding capability, staple form and height as well as other stapling parameters.
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
MAY 17 199
Image /page/0/Picture/1 description: The image shows a sequence of characters, seemingly handwritten. The sequence appears to be "K91030". The characters are bold and black against a white background.
510(k) Summary of Safety and Effectiveness (App. A)
| Contact | Edwin O. Billips, Senior Associate Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242 Telephone (513) 786-7162 Fax (513) 786-7134 |
|---|---|
| Date | March 26, 1999 |
| Device | Name: Circular Stapler and accessories Classification Name: Endoscope and Accessories Common Name: Circular Stapler Trade Name /Proprietary Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories |
| Legally marketed device | PROXIMATE® Curved and Straight Intraluminal Staplers (K983536). |
| Device description | PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories is available in a 33 mm diameter size only. The instruments allow the surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed to facilitate insertion, operation and removal.. |
| Intended use | The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. |
1
510(k) Summary of Safety and Effectiveness (App. A)
| Indications
statement | The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories
have application throughout the anal canal to perform surgical treatment for
hemorrhoidal disease. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories
technological characteristics are identical to those described in the Predicate
Device. |
| Performance
data | Pre-clinical laboratory evaluations were performed to ensure that the device
can be used as designed. The studies demonstrated acceptable performance to
the Predicate Device in pressure holding capability, staple form and height as
well as other stapling parameters. |
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 1999
Mr. Edwin O. Billips, RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K991030
Trade Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories Regulatory Class: II Product Code: GDW Dated: March 26, 1999 Received: March 29, 1999
Dear Mr. Billips:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Edwin O. Billips
This letter will allow you to begin marketing your device as described in your 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 device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement (App. C)
Following is the Indications for Use Statement: Statement
510(k) Number: K Device Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories
Indications for Use: The PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
D. O'Dell
livision Sid ivision of G neral Restors 510(k) Number