(90 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical function and equivalence to a predicate device, with no mention of AI or ML.
No.
The device facilitates a medical procedure (establishment of pneumoperitoneum) rather than directly treating a disease or condition.
No.
The device's intended use is to establish pneumoperitoneum, a procedure for creating space in the abdominal cavity for other minimally invasive procedures, not for diagnosing a condition. Its function involves mechanical action (inserting a needle) rather than analyzing biological signals or images for diagnostic purposes.
No
The device description clearly describes a physical needle with a handle, stopcock, and luer lock connector, indicating it is a hardware 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 is "the establishment of pneumonperitoneum" for surgical procedures. This is a direct intervention on the patient's body for a surgical purpose.
- Device Description: The description details a mechanical device (needle, stylet, handle, stopcock, luer lock) used to physically create a space in the abdomen.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
This device is clearly a surgical instrument used for a procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
85 HIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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)
Bench data was used to evaluate the performance to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in reliability and design. The performance criteria evaluated are flow rate, spring force to deflect stylet, audible rate, and needle penetration. From the data generated, it can be concluded that the New Device performed equivalent to the Predicate Device.
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.
Not Found
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
§ 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.
0
(
Appendix A: 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under the
Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is
summarized below. For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule "...510(k) Summaries
and 510(k) Statements..." (21 CFR §807) and can be used to provide a
substantial equivalence summary to anyone requesting it from the Agency. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | 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. |
| Intended use | The intended use of the New Device is the establishment of
pneumonperitoneum. |
| Indications | The ENDOPATH® Ultra Veress Insufflation Needle has applications in
gynecologic laparoscopy and other minimally invasive abdominal procedures
for establishment of pneumonperitoneum. |
| Contra-
indications | The instrument is not intended for use when minimally invasive techniques
are contraindicated. |
| Technological
characteristics | The technological characteristics of the New Device are the same as the
Predicate Device. |
| Performance
data | Bench data was used to evaluate the performance to ensure that the device can
be used as designed. The studies demonstrated acceptable performance to the
Predicate Device in reliability and design. The performance criteria evaluated
are flow rate, spring force to deflect stylet, audible rate, and needle
penetration. From the data generated, it can be concluded that the New
Device performed equivalent to the Predicate Device. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the
information provided herein, we conclude that the New Device is
substantially equivalent to the Predicate Device under the Federal Food, Drug
and Cosmetic Act. |
| Contact | Edwin O. Billips, RAC
Senior Associate
Regulatory Affairs
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | November 2, 1998 |
Continued on next page
1
Appendix A: 510(k) Summary of Safety and Effectiveness,
Continued
ﺎﻣﮧ ﺳ
2
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
3
Page 1 of 1
s ''
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.
(PL): ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 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) |