(72 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description indicates no change from previous predicate devices, which are mechanical linear cutters/staplers.
No
The device is described as a surgical tool for cutting, resecting, and anastomosing tissues, and for coagulation, not for treating a disease or condition.
No
The device is a surgical tool used for transection, resection, creation of anastomoses, and coagulation of tissue, not for diagnosing medical conditions.
No
The device description and intended use clearly describe surgical instruments (linear cutters and staplers) which are hardware devices used for transection, resection, and creation of anastomoses. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use statements clearly describe the device's function as a surgical tool for cutting, resecting, and creating connections (anastomoses) of internal tissues. This is a direct surgical intervention on the patient's body.
- Device Description: The description focuses on the physical and performance characteristics of a surgical instrument (linear cutter/stapler).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The ENDOPATH® and PROXIMATE® Linear Cutters are intended for transection, resection, and/or creation of anastomoses.
Product codes
GCJ
Device Description
All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) have not changed from the above-mentioned 510(k)s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The Disposable Linear Stapler has application in abdominal, thoracic, and pediatric surgery for resection and transection of internal tissues. The total thickness of the tissues being connected must be within the range of 1.0 to 3.0 mm.
The PLC50 has application in abdominal, pediatric and thoracic surgery for resection, transection and creation of anastomoses.
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 ENDOPATH® and PROXIMATE® Linear Cutters' performances have not changed from the above-mentioned 510(k)s.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K821994, K843034, K892927, K915099, K930934, K935064, K945202
Reference Device(s)
K951546, K961264, K961390, K970720
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a black and white graphic of a circle with lines emanating from the upper right quadrant. The lines are thick and appear to be converging towards a central point outside the circle. The lower left quadrant of the circle is shaded with a stippled effect, creating a contrast with the rest of the circle.
ETHICON ENDO-SURGERY, INC. a Johnson Johnson company
980023
MAR 1 8 1998
4545 CREEK ROAD
CINCINNATI, OH 45242-2839
510(k) Summary of Safety and Effectiveness
| Contact | Lorri Chavez, Project Manager
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242
Telephone: (513) 483-3513 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date prepared | January 2, 1998 |
| Device | Name: ENDOPATH® and PROXIMATE® Linear Cutters
Classification Name: Endoscope and Accessories
Common Name: Linear Cutter
Trade Name/Proprietary Name: ENDOPATH® and PROXIMATE® Linear
Cutters |
| Legally
marketed
devices | Linear Stapler (LSR) - Rigid (K821994);
Disposable Linear Cutter (K843034);
PROXIMATE® Linear Cutter Thick Tissue Instrument (K892927);
ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and
Reloading Unit (K915099);
ENDOPATH® Reloadable Linear Cutter with Safety Lock-Out and
Reloading Unit (K930934);
Modified ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and
Reloading Unit (No-Row) (K935064);
Modified ENDOPATH® Endoscopic Reloadable Linear Cutter with Safety
Lockout and Reload Unit (K945202); |
Continued on next page
1
510(k) Summary of Safety and Effectiveness, Continued
| Legally
marketed
devices, cont'd | New Indication for ENDOPATH® and PROXIMATE® Linear Cutters and
Staplers (K951546);
ENDOPATH® EZ-RF Linear Cutter and Coagulation Device (K961264);
ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic
Articulating Linear Cutter Devices (K961390); and,
ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No
Knife Endoscopic Linear Stapler (K970720). |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | All device functions, scientific concepts, significant physical and performance
characteristics (i.e. device design, materials, physical properties, etc.) have not
changed from the above-mentioned 510(k)s. |
| Intended use | The ENDOPATH® and PROXIMATE® Linear Cutters are intended for
transection, resection, and/or creation of anastomoses. |
| Indications
statement | The ENDOPATH® and PROXIMATE® Linear Cutter indication statements
have not changed from the above-mentioned 510(k)s. |
| Technological
characteristics | The ENDOPATH® and PROXIMATE® Linear Cutter technological
characteristics have not changed from the above-mentioned 510(k)s. |
| Performance
data | The ENDOPATH® and PROXIMATE® Linear Cutters' performances have
not changed from the above-mentioned 510(k)s. |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 1998
Ms. Lorri Chavez Project Manager Requlatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road 45242-2839 Cincinnati, Ohio
K980023 Re: Endopath® and Proximate® Linear Cutters Trade Name: Requlatory Class: II Product Code: GCJ 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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ 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 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 requlation (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,
Stephen Rhodes
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. B)
Indications for Use Statement: Statement
510(k) Number: K 980023
Device Name: ENDOPATH® and PROXIMATE® Linear Cutters
K821994: The Disposable Linear Stapler has application in abdominal, thoracic, and pediatric surgery for resection and transection of internal tissues. The total thickness of the tissues being connected must be within the range of 1.0 to 3.0 mm.
K843034: The PLC50 has application in abdominal, pediatric and thoracic surgery for resection, transection and creation of anastomoses.
K892927: The LCT75 has application in gastrointestinal and thoracic surgery for resection, transection and creation of anastomoses. Cartridges for the standard (PLC75) and Thick Tissue (LCT75) are interchangeable within these instruments.
K915099: The ENDOPATH Endoscopic Linear Cutter with Safety Lock-out has applications multiple open or endoscopic procedures for the transection, resection and creation of anastomosis.
K930934: The ENDOPATH Endoscopic Reloadable Linear Cutter with Safety Lock-Out has application in gastrointestinal and thoracic surgery for transection, resection and creation of anastomoses.
K935064: The ENDOPATH Endoscopic Linear Cutter with Safety Lock-Out has application in multiple open or endoscopic procedures for the transection, resection, and creation of anastomoses.
K945202: The ENDOPATH Endoscopic Reloadable Linear Cutter with ----------Safety Lock-Out has multiple open or endoscopic procedures for transection. resection and/or creation of anastomoses.
Continued on next page
5
Indications for Use Statement (App. B), Continued
K951546: [Verbiage for all of the various indication statements remain the Statement. continued same, plus] ... and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
K961264: The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators.
K961390: The ENDOPATH ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
K970720: The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open or other minimally invasive surgical procedures for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium. and
The ENDOPATH EZ45 No Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection and resection, and can be used with staple line or buttressing materials, such as bovine pericardium.
Stipta Plwelu
ivision Sign-Off) ision of General Restorative Devices 980023 10(k) Number
Prescription Use
X
(Per 21 CFR 801.109)
Over-the-Counter Use