(63 days)
Not Found
No
The summary explicitly states that the device functions and characteristics have not changed from the predicate device (K972679) and there is no mention of AI, ML, or related concepts.
No
The device is used for approximating soft tissue with stitches during minimally invasive surgical applications, which is a structural rather than a therapeutic function.
No
The device is described as a tissue fastening system and suture used for soft tissue approximation in surgical applications, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly refers to a "System" and mentions "device design, materials, physical properties," indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches." This describes a surgical tool used on the body, not a device used to test samples from the body (which is what IVDs do).
- Device Description: The description focuses on the physical characteristics and function of a surgical fastening system and suture.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.
ETHIBOND EXCEL Polyester Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GAT
Device Description
All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) have not changed in design or manufacture from 510(k) #972679.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Not Found
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
ETHICON ENDO-SURGERY, INC.
company
980022
| 4545 CREEK ROAD
| CINCINNATI, OH 45242-2839 | 510(k) Summary of Safety and Effectiveness | MAR - 9 |
|---|---|---|
| Contact | Lorri Chavez, Project Manager | |
| Ethicon Endo-Surgery, Inc. | ||
| 4545 Creek Road | ||
| Cincinnati, Ohio 45242 | ||
| Telephone: (513) 483-3513 | ||
| Date | January 2, 1998 | |
| Device | Name: ENDOPATH® Endoscopic Tissue Fastening System (ETFS) | |
| Classification Name: Manual Surgical Instrument | ||
| Common Name: Knot Tying Instrument | ||
| Trade Name/Proprietary Name: ENDOPATH® Endoscopic Tissue Fastening | ||
| System (ETFS) | ||
| Legally | ||
| marketed | ||
| device | ENDOPATH® Endoscopic Tissue Fastening System (ETFS) (K972679). | |
| Device | ||
| description | All device functions, scientific concepts, significant physical and performance | |
| characteristics (i.e. device design, materials, physical properties, etc.) have not | ||
| changed in design or manufacture from 510(k) #972679. | ||
| Intended use | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended | |
| for use where soft tissue is being approximated. | ||
| Indications | ||
| statement | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) indication | |
| statement has not changed from 510(k) #972679. | ||
| Technological | ||
| characteristics | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) | |
| technological characteristics have not changed from 510(k) #972679. | ||
| Performance | ||
| data | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) | |
| performance has not changed from 510(k) #972679. |
ext page
1
510(k) Summary of Safety and Effectiveness, Continued
:
ﻨﻴﺔ ﺍﻟﺘﺴﻴﻴﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ
ETHICON ENDO-SURGERY, INC. New Contraindication for the ENDOPATH® Endoscopic Tissue Fastening System (ETFS)
. . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1000
Ms. Lorri Chavez · Project Manager Requlatory Affairs Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati, Ohio 45242-2839
K980022 Re: Trade Name: ENDOPATH® Endoscopic Tissue Fasteninq System (ETFS) Regulatory Class: II Product Code: GCJ and GAT Dated: January 2, 1998 Received: January 5, 1998
Dear Ms. Chavez:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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. ಕ್ಕೆ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 - Ms. Chavez
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,
Scalef
☑ Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Derig
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement (App. B)
Statement
Indications for Use Statement:
510(k) Number: K 980022
Device Name: ENDOPATH® Endoscopic Tissue Fastening System (ETFS)
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.
ETHIBOND EXCEL Polyester Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Prescription Use
(Per 21 CFR 801.109) X
bicolezo
General Restorative Device
ETHICON ENDO-SURGERY, INC. New Contraindication for the ENDOPATH® Endoscopic Tissue Fastening System (ETFS)