(70 days)
Not Found
No
The summary explicitly states that the device functions and characteristics are identical to a predicate device from 1994 (K940967), and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is a surgical stapler used for creating anastomoses; it is not described as directly administering therapy or treating a condition through non-surgical means. It is a tool used during a surgical procedure.
No
The PROXIMATE® Curved and Straight Intraluminal Staplers are used for surgical treatment (anastomoses and hemorrhoidal disease), not for diagnosing conditions.
No
The device description explicitly states it is a stapler, which is a physical medical 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 within the body for creating anastomoses in the alimentary tract and anal canal. This is a surgical procedure performed in vivo (within a living organism).
- Device Description: The description confirms it's a surgical stapler.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are typically used to test samples like blood, urine, tissue, etc., in a laboratory setting to diagnose or monitor conditions. This device is a surgical tool used directly on the patient's tissues during surgery.
N/A
Intended Use / Indications for Use
The PROXIMATE® Curved and Straight Intraluminal Staplers have application throughout the alimentary tract for end to end, end to side and side to side anastomoses.
The PROXIMATE® Curved and Straight Intraluminal Staplers have application throughout the alimentary tract for end to end, end to side and side to side anastomoses, have application throughout the anal canal to perform surgical treatment for hemorrhoidal disease.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
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) #940967.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, 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)
The PROXIMATE® Curved and Straight Intraluminal Staplers' performances are identical to that described in 510 (k) #940967.
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
1 8
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K483536'. The characters are written in a bold, brush-like style, giving them a distinct and somewhat artistic appearance. The numbers are clearly distinguishable, and the overall image has a high contrast due to the dark ink on a light 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 | October 3, 1998 |
| Device | Name: PROXIMATE® Curved and Straight Intraluminal Staplers
Classification Name: Endoscope and Accessories
Common Name: Circular Stapler
Trade Name /Proprietary Name: PROXIMATE® Curved and Straight
Intraluminal Staplers |
| Legally
marketed
device | Modified ENDOPATH® ILS Circular Stapler (K940967). |
| Device
description | 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) #940967. |
| Intended use | The PROXIMATE® Curved and Straight Intraluminal Staplers have
application throughout the alimentary tract for end to end, end to side and side
to side anastomoses. |
| Indications
statement | The PROXIMATE® Curved and Straight Intraluminal Staplers have
application throughout the alimentary tract for end to end, end to side and side
to side anastomoses, have application throughout the anal canal to perform
surgical treatment for hemorrhoidal disease. |
| Technological
characteristics | The PROXIMATE® Curved and Straight Intraluminal Staplers technological
characteristics are identical to those described in 510(k) #940967. |
| Performance
data | The PROXIMATE® Curved and Straight Intraluminal Staplers' performances
are identical to that described in 510 (k) #940967. |
1
510(k) Summary of Safety and Effectiveness (App. A)
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1998
Edwin O. Billips, RAC Senior Associate Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
K983536 Re:
Trade Name: PROXIMATE® Curved and Straight Intraluminal Staplers Regulatory Class: II Product Code: GDW Dated: October 8, 1998 Received: October 9, 1998
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 (QS) 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, RAC
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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Statement
Following is the Indications for Use Statement:
510(k) Number: K 983536 Device Name: PROXIMATE® Curved and Straight Intraluminal Staplers
Indications for Use:
The PROXIMATE® Curved and Straight Intraluminal Staplers have application throughout the alimentary tract for end to end, end to side and side to side anastomoses including application throughout the anal canal to perform surgical treatment for hemorrhoidal disease.
pcotello
(Division Sign-Off) Division of General Restorative Devices KG 835.3 510(k) Number
Prescription Use
(Per 21 CFR 801.109)