(88 days)
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No
The document describes mechanical surgical staplers and cutters and does not mention any AI or ML components or functionalities.
No.
The device is described as an instrument for surgical procedures like transection, resection, and anastomoses creation. While it aids in treatment, it does not directly administer therapy, deliver medication, or provide a therapeutic effect on its own; it's a surgical tool.
No
The device is described as surgical instruments used for transection, resection, and/or creation of anastomoses, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a sterile, single patient use instrument that delivers staples, indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures involving transection, resection, and creation of anastomoses within the body. This is a surgical device used on the patient, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details a surgical instrument that delivers staples. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for physical manipulation of tissue during surgery.
N/A
Intended Use / Indications for Use
The ENDOPATH® ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact- Flex45 Articulating Linear Cutter are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium.
The ENDOPATH® ETS Flex45 No-Knife Articulating Linear Staplers and ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium.
Product codes (comma separated list FDA assigned to the subject device)
OCW
Device Description
The ENDOPATH® ETS45 Linear Cutters, Linear Staplers and Reloads are sterile, single patient use instruments that deliver two or three double-staggered rows of staples.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Pediatric
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical testing was performed to ensure that the devices performed as intended. Testing demonstrated satisfactory performance in transection, resection, and/or creation of anastomoses. The modified device will provide increased clamping force when the anvil and channel (which holds the cartridge) is clamped down across tissue, resulting in more consistent staple formation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/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 an eagle with three curved lines representing its wings and tail feathers. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, Inc. Mr. Edwin O. Billips Senior Associate, Regulatory Affairs 4545 Creek Road Cincinnati, OH 45242-2839
·JUL 2 7 2015
Re: K002398
Trade/Device Name: Endopath ETS45 Endoscopic Linear cutters: Flex 45 Endoscopic Articulating Linear cutters; ETS Compact-Flex 45 Articulating Linear cutter; ETS Flex 45 No-Knife Articulating Linear staplers, and ETS Compact-Flex 45 No-Knife Articulating Linear staplers
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: OCW
Dated (Date on orig SE ltr): August 3, 2000
Received (Date on orig SE Itr): August 7, 2000
Dear Mr. Billips,
This letter corrects our substantially equivalent letter of November 3, 2000.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The ENDOPATH® ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact- Flex45 Articulating Linear Cutter are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including appiated on managed and pediatic surgical procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium.
The ENDOPATH® ETS Flex45 No-Knife Articulating Linear Staplers and ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), theracic, and pediatic procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium.
(PLEASE DO NOT WRITE BELOW THIS UNE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mark N. Millman | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K002398 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
Presc (Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
3
Ethicon Endo-Surgery, Inc ENDOPATH® ETS45 Linear Cutters, Staplers, and Reloads
Section L
510(k) Summary of Safety and Effectiveness (2 copies)
Company:
Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
Contact:
Edwin O. Billips Senior Regulatory Associate Telephone: 513- 337-7162 Fax: 513- 337-7134
Date Prepared: August 3, 2000
Modified Devices: ENDOPATH® ETS45 Linear Cutters, Linear Staplers and Reloads
Marketed Devices: ENDOPATH® ETS45 Linear Cutters, Linear Staplers and Reloads
Device Description:
The ENDOPATH® ETS45 Linear Cutters, Linear Staplers and Reloads are sterile, single patient use instruments that deliver two or three double-staggered rows of staples.
Indication For Use:
The ENDOPATH® ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact- Flex45 Articulating Linear Cutter are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectorny), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium.
The ENDOPATH® ETS Flex45 No-Knife Articulating Linear Staplers and ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and
380:\510(k)s\K00_ lets510.doc 8/3/00
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KOO 2398
Ethicon Endo-Surgery, Inc ENDOPATH® ETS45 Linear Cutters, Staplers, and Reloads
pediatric procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium.
Technological characteristics:
The technological characteristics of the modified devices are the similar to the marketed products. The modified devices are linear cutters/staplers that are used for transection, resection, and/or creation of anastomoses.
Performance Data:
Preclinical testing was performed to ensure that the devices performed as intended. Testing demonstrated satisfactory performance in transection, resection, and/or creation of anastomoses. The modified device will provide increased clamping force when the anvil and channel (which holds the cartridge) is clamped down across tissue, resulting in more consistent staple formation.
Conclusion:
Based on 21CFR § 807, we conclude that the modified products are as safe and effective as the marketed devices.