(207 days)
The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
The ENDOPATH Endoscopic Instruments are sterile, single patient use instruments designed for use through appropriate ENDOPATH Surgical Trocars and FLEXIPATH® Flexible Surgical Trocars. The instruments have a rotating insulated shaft with a diameter of either 3mm, 5mm or 10mm. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The ring handles are compressed and released to activate the instrument jaws or scissor blades. Each of the curved scissors and dissectors has a monopolar cautery connector that extends from the top of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and a proper generator.
The provided 510(k) summary for the ENDOPATH® Endoscopic Instruments describes a medical device and its substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria, a specific study with quantitative performance metrics, or information relevant to AI/ML or extensive clinical trials as implied by many of your requested categories.
This device is a surgical instrument from 1999, and the regulatory submission approach for such devices
is typically based on demonstrating substantial equivalence through design comparisons and pre-clinical bench testing, rather than the rigorous performance studies often associated with AI/ML-driven diagnostics where the requested details would be highly applicable.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text. I will address what can be extracted or inferred.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it states:
- Acceptance Criteria (Implied): Acceptable performance equivalent to the Predicate Device in reliability and design.
- Reported Device Performance: "The studies demonstrated acceptable performance to the Predicate Device in reliability and design. The performance evaluated are ergonomics of the handle and rotating knob tissue trauma, grasping, dissecting, cauterizing ability and cutting ability. From the date generated, it can be concluded that the New Device performs equivalent to the Predicate Device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The performance evaluation refers to "pre-clinical data" and "studies" but gives no details on sample size, data provenance, or whether the studies were retrospective or prospective. Given the nature of a surgical instrument, these tests would likely be in-vitro or ex-vivo bench tests, possibly animal models, rather than human clinical trials for a 510(k) submission focused on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. It's unlikely that "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy (as would be relevant for AI) were involved in a way that would require detailed reporting for this type of device. The evaluations would more likely involve engineers or technicians assessing mechanical and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for complex diagnostic interpretations, not for the functional testing of a surgical instrument.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was done. This is a surgical instrument, not an AI-based diagnostic tool. "Human readers" and "AI assistance" are not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states performance was evaluated on "ergonomics of the handle and rotating knob tissue trauma, grasping, dissecting, cauterizing ability and cutting ability." The "ground truth" would be objective measurements or qualitative assessments of these physical properties and functions against pre-defined engineering specifications or performance of the predicate device. It would not be expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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K 984240
JUN 22 2 1999
510(k) Summary of Safety and Effectiveness
| Submitter | Ethicon Endo-Surgery, Inc.4545 Creek Rd.Cincinnati, OH 45242 |
|---|---|
| Contact | Jackie A. Strasser, MT (ASCP), MSRegulatory Affairs AssociateTelephone (513) 786-7978 Fax (513) 786-7134 |
| Date | November 23, 1998 |
| New Device | Name: ENDOPATH® Endoscopic InstrumentsClassification Name: Electrosurgical Cutting and Coagulation Device and AccessoriesCommon Name: Laparoscopic Surgical InstrumentsTrade Name/Proprietary Name: ENDOPATH® Endoscopic Instruments |
| Legallymarketeddevice | The Predicate Device legally marketed under K910831:[Symbiosis] ENDOPATH Endoscopic Instruments |
| Devicedescription | The ENDOPATH Endoscopic Instruments are sterile, single patient use instruments designed for use through appropriate ENDOPATH Surgical Trocars and FLEXIPATH® Flexible Surgical Trocars. The instruments have a rotating insulated shaft with a diameter of either 3mm, 5mm or 10mm. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The ring handles are compressed and released to activate the instrument jaws or scissor blades. Each of the curved scissors and dissectors has a monopolar cautery connector that extends from the top of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and a proper generator. |
Continued on next page
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:
:
510(k) Summary of Safety and Effectiveness, Continued
| Intended use | The ENDOPATH Endoscopic Instruments have application in a variety ofminimally invasive procedures to facilitate grasping, mobilization, dissectionand transection of tissue. |
|---|---|
| Technologicalcharacteristics | The technological characteristics of the New Device are the same as thePredicate Device. |
| Performancedata | Pre-clinical data were used to evaluate the performance to ensure that thedevice can be used as designed. The studies demonstrated acceptableperformance to the Predicate Device in reliability and design. Theperformance evaluated are ergonomics of the handle and rotating knob tissuetrauma, grasping, dissecting, cauterizing ability and cutting ability. From thedate generated, it can be concluded that the New Device performs equivalentto the Predicate Device. |
| Conclusion | Based on the information provided herein and the Decision-Making ProcessChart (Appendix E), we conclude that the New Device is substantiallyequivalent to the Predicate Device under the Federal Food, Drug andCosmetic Act. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol resembles a stylized caduceus, featuring a staff with intertwined snakes and a pair of wings at the top. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1999
Ms. Jackie A. Strasser, MT (ASCP), MS Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K984240
. .
Trade Name: ENDOPATH® Endoscopic Instruments Regulatory Class: II Product Code: GEI Dated: March 22, 1999 Received: March 24, 1999
Dear Ms. Strasser:
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 (OS) 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.
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Page 2 - Ms. Jackie A. Strasser, MT (ASCP), MS
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,
focottefa
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
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Indications for Use Statement Appendix A
The following is the Indications for Use Statement: Statement
510(k) Number: K 984240 Device Name: ENDOPATH Endoscopic Instruments
Indications for Use:
The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
(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) | X |
|---|---|
| ------------------------------------------ | --- |
OR
Over-The-Counter-Use (Optional Format 1-2-96)
.; ''
Pcostelo
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.