(90 days)
The intended use of the New Device is the establishment of pneumonperitoneum.
The ENDOPATH® Ultra Veress Insufflation Needle has applications in gynecologic laparoscopy and other minimally invasive abdominal procedures for establishment of pneumonperitoneum.
The ENDOPATH® Ultra Veress Insufflation Needle is a spring-loaded, blunt stylet safety mechanism similar in function to a Veress needle. It is used to establish pneumoperitoneum prior to abdominal endoscopy. The 14 gauge stainless steel needle is attached at its proximal end to a plastic handle. The handle is shaped for comfort in the hand and contains a stopcock and a luer lock connector for insufflating the abdominal cavity. Inside the needle sleeve and extending beyond the needle tip is a spring-loaded, blunt stylet. The stylet retracts as the needle is pushed through the abdominal tissue and automatically advances forward once the peritoneum is established.
The provided text describes a 510(k) summary for the ENDOPATH® Ultra Veress Insufflation Needle. This submission is for a medical device that establishes pneumoperitoneum, and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device, rather than proving diagnostic performance in the way an AI algorithm or diagnostic test would be evaluated.
Here's the breakdown based on your request, adapted for this type of medical device submission:
Acceptance Criteria and Study for ENDOPATH® Ultra Veress Insufflation Needle
The acceptance criteria for the ENDOPATH® Ultra Veress Insufflation Needle are established by demonstrating that its performance is equivalent to a legally marketed predicate device. This is a common approach for 510(k) submissions, where the new device is shown to be substantially equivalent in terms of safety and effectiveness to an already approved device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Flow Rate | Equivalent to Predicate Device |
| Spring Force to Deflect Stylet | Equivalent to Predicate Device |
| Audible Rate | Equivalent to Predicate Device |
| Needle Penetration | Equivalent to Predicate Device |
Note: The document explicitly states "From the data generated, it can be concluded that the New Device performed equivalent to the Predicate Device." This "equivalence" is the core of meeting the acceptance criteria for a 510(k) pathway.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes used for the bench tests. It broadly states "Bench data was used to evaluate the performance."
- Data Provenance: The studies were bench studies conducted by the manufacturer, Ethicon Endo-Surgery, Inc. The exact country of origin is not explicitly stated for the data generation, but the manufacturer is based in Cincinnati, Ohio, USA. The studies are prospective in the sense that they were designed and executed to evaluate the new device's performance against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to this type of device submission. The "ground truth" here is the established performance characteristics of the predicate device, not expert consensus on medical images or diagnoses. The FDA evaluates the submission based on engineering and performance data compared to the predicate, and does not involve experts establishing ground truth in the diagnostic sense for these comparisons.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or subjective interpretations. For objective bench performance tests comparing device characteristics, an adjudication method is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic aid (often AI) on human reader performance, usually in interpreting medical images or data. The ENDOPATH® Ultra Veress Insufflation Needle is a surgical instrument, and its evaluation focuses on physical performance characteristics rather than diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of "standalone" evaluation was done. The performance data presented (flow rate, spring force, audible rate, needle penetration) represent the intrinsic, standalone performance of the device itself, without a "human-in-the-loop" directly influencing these physical metrics during the test. The human element would be in using the device, but the tests evaluate its inherent mechanical and functional characteristics.
7. The Type of Ground Truth Used:
- The "ground truth" for this comparative evaluation is the established and legally marketed performance of the predicate device. The new device's performance metrics were compared to those of the predicate device to establish substantial equivalence.
8. The Sample Size for the Training Set:
This question is not applicable. The device is a mechanical surgical instrument, not an AI algorithm or a statistical model that requires a "training set" in the computational sense. The "training" for such a device would be the engineering design and manufacturing processes, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reasons as #8. There is no "training set" or corresponding ground truth establishment in the context of an AI or statistical model.
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Appendix A: 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under theFederal Food, Drug and Cosmetic Act, respecting safety and effectiveness issummarized below. For the convenience of the Reviewer, this summary isformatted in accordance with the Agency's final rule "...510(k) Summariesand 510(k) Statements..." (21 CFR §807) and can be used to provide asubstantial equivalence summary to anyone requesting it from the Agency. |
|---|---|
| Devicedescription | The ENDOPATH® Ultra Veress Insufflation Needle is a spring-loaded, bluntstylet safety mechanism similar in function to a Veress needle. It is used toestablish pneumoperitoneum prior to abdominal endoscopy. The 14 gaugestainless steel needle is attached at its proximal end to a plastic handle. Thehandle is shaped for comfort in the hand and contains a stopcock and a luerlock connector for insufflating the abdominal cavity.Inside the needle sleeve and extending beyond the needle tip is a spring-loaded, blunt stylet. The stylet retracts as the needle is pushed through theabdominal tissue and automatically advances forward once the peritoneum isestablished. |
| Intended use | The intended use of the New Device is the establishment ofpneumonperitoneum. |
| Indications | The ENDOPATH® Ultra Veress Insufflation Needle has applications ingynecologic laparoscopy and other minimally invasive abdominal proceduresfor establishment of pneumonperitoneum. |
| Contra-indications | The instrument is not intended for use when minimally invasive techniquesare contraindicated. |
| Technologicalcharacteristics | The technological characteristics of the New Device are the same as thePredicate Device. |
| Performancedata | Bench data was used to evaluate the performance to ensure that the device canbe used as designed. The studies demonstrated acceptable performance to thePredicate Device in reliability and design. The performance criteria evaluatedare flow rate, spring force to deflect stylet, audible rate, and needlepenetration. From the data generated, it can be concluded that the NewDevice performed equivalent to the Predicate Device. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and theinformation provided herein, we conclude that the New Device issubstantially equivalent to the Predicate Device under the Federal Food, Drugand Cosmetic Act. |
| Contact | Edwin O. Billips, RACSenior AssociateRegulatory AffairsEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
| Date | November 2, 1998 |
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Appendix A: 510(k) Summary of Safety and Effectiveness,
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Image /page/2/Picture/2 description: The image shows a black and white seal for the Department of Health & Human Services USA. The seal is circular with text around the perimeter. Inside the circle is an emblem of an eagle with three stylized lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 1999
Edwin O. Billips, RAC Senior Associate, Regulatory Affairs ETHICON ENDO-SURGERY, INC. 4545 Creek Road Cincinnati, OH 45242-2839
Re: K983925
ENDOPATH® Ultra Veress Insufflation Needle Dated: November 2, 1998 Received: November 5, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF
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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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.
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 Compirance at (301) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
J.J.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
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510(k) Number (if known)
Device Name
Indications for use
ENDOPATH® Ultra Veress Insufflation Needle
The ENDOPATH® Ultra Veress Insufflation Needle has
Insufficial Ultra Veress soony and other The ENDOPATII - Olda - Startoscopy and other applications in gyllectilegie hiparesess for establishment
minimally invasive abdominal procedures for establishment of preumoperitoneum.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983925 |
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.