(238 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical aspects of a Veress needle, with no mention of AI or ML.
No
The device is used for insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures, which is a preparatory step for surgery, not a therapeutic intervention itself.
No
The device is described as a Veress needle used for insufflation to establish pneumoperitoneum for laparoscopic procedures, which is a preparatory step for surgery, not a diagnostic one. The performance tests also focus on mechanical operation, not diagnostic accuracy.
No
The device description clearly describes a physical, sterile, disposable needle with mechanical components (spring-loaded obturator, slide switch, luer lock connector) and performance studies focused on physical characteristics (tip pull, switch operation, puncture force). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous insertion into the peritoneal cavity for insufflation with carbon dioxide during laparoscopic procedures. This is a surgical procedure performed on a patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
This device is a surgical instrument used directly on a patient, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
The GeniCon Pnuemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Product codes
85 HIF
Device Description
The GeniCon, Pneumo-Needle is a sterile, disposable Veress needle which is available in 120mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a malue luer lock connector for secure CO2 gas line connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal 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
A series performance tests were performed on the GeniCon Pneumo-Needle to inspect such areas as:
- Tip Pull Test
- Switch Operation
- Spring Obturator Operation
- Needle Puncture Force Test
Key Metrics
Not Found
Predicate Device(s)
Apple Medical's Pneumo-Matic Insufflation Needle
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 2 0 2000
Section II. 510(k) Summary
Page: II-1
GeniCon L.C. Contact: Gary Haberland 573 Waterscape Way Orlando, FL 32828 Phone: (407) 273-7619 Fax: (407) 306-9356
Date Prepared: October 19, 1999
Trade Name: GeniCon Pneumo-Needle Common Name: Veress Needle Classification Name: According to Section 513 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards (21 CFR 884.1730).
| Predicate Device: | Apple Medical's Pneumo-Matic Insufflation Needle |
|---|---|
| 580 Main Street | |
| Bolton, MA 01740 |
Product Description:
The GeniCon, Pneumo-Needle is a sterile, disposable Veress needle which is available in 120mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a malue luer lock connector for secure CO2 gas line connection.
Indications for Use:
The GeniCon Pnuemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Performance:
A series performance tests were performed on the GeniCon Pneumo-Needle to inspect such areas as:
- Tip Pull Test 1.
-
- Switch Operation
- Spring Obturator Operation 3.
-
- Needle Puncture Force Test
Conclusion:
Based on the indications for use, technological characteristics and performance testing, the GeniCon Pneumo-Needle has been shown to be effective for its intended use and substantially equivalent to the predicate device.
Image /page/0/Picture/20 description: The image shows the logo for GeniCon, a company that provides new ideas for modern health care. The logo features the company name in a bold, sans-serif font, with the "C" in "Con" replaced by a circle with two surgical instruments inside. Below the logo is the tagline "New Ideas for Modern Health Care" in a smaller, serif font. The logo is simple and professional, and it conveys the company's focus on innovation and healthcare.
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized bird design. The bird is composed of three curved lines that suggest movement or flight. The logo is encircled by text, though the text is not clear enough to read. The overall design is simple and abstract.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2000
Mr. Gary Haberland Product Manager GeniCon L.C. 573 Waterscape Way Orlando, FL 32828
Dear Mr. Haberland:
Re: K993625 GeniCon Pneumo-Needle Dated: March 31, 2000 Received: April 3, 2000 Regulatory Class: II 21 CFR §884.1730/Procode: 85 HIF
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 Cosmelic 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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, Tille 21, Parts 800 to 895. A substantially equivation assumes compliance with the Ourrent Good Manufacturing Practice requirements, 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 action. In addition, FDA may publish further announcements concerning vour device in the Federal Register. Please note: this response to your premarket not ification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication for your device and thus, permits your device to proceed to the market.
If you desre specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnosic devices), please contact the Office of Compliance at (301) 594-4591. 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" (21CFR 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/dsmaldsmamain.html"
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
2
Section I. Indications for Use
K993625 510 (k) Number: unassigned neumo - Needle Device Name:
Indications for Use:
The GeniCon Pnutemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
✓
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
David A. Nyarron
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT) and Radiological Devices 510(k) Number
Image /page/2/Picture/11 description: The image shows the logo for GeniCon, a company that provides new ideas for modern healthcare. The logo features the company name in a bold, sans-serif font, with a stylized image of surgical instruments forming the "C" in "Con". Below the company name is the tagline "New Ideas for Modern Health Care".
Page: I-1