(81 days)
No
The document describes a mechanical insufflation cannula and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as an insufflation cannula used for establishing a pneumoperitoneum in laparoscopic operations, which is an interventional surgical step, not a therapeutic treatment itself.
No
The device, an insufflation cannula, is used for initial puncture and gas insufflation to establish a pneumoperitoneum during laparoscopic operations, which is a procedural step rather than a diagnostic one.
No
The device description clearly describes a physical medical device (insufflation cannula) used for surgical procedures, not a software-only application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is an "insufflation cannula" used for "initial puncture with subsequent gas insufflation for laparoscopic operations" to "establish a pneumoperitoneum." This is a surgical tool used within the body for a surgical procedure.
- Lack of Specimen Testing: There is no mention of the device being used to test any biological specimens.
Therefore, based on the provided information, the Pajunk insufflation cannula acc. Veress and the modular insufflation cannula acc. Veress are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Pajunk insufflation cannula acc. Veress and the modular insufflation cannula acc. Veress is employed in minimal invasive surgery. The cannula is designed for the initial puncture with subsequent gas insuffation for laparoscopic operations. It is used to establish a pneumoperitoneum.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, NLM, HET
Device Description
The insufflation cannulae according Veress were developed especially for the safe and efficient r rio moumation oannalae and insufflation cannulae are equipped with maintenance free cocks and a female LuerLock connector. Before application, a sharp outer cannula (sterile packed for modular Veress, reusable for Standard Veress) is mounted onto the reusable inner cannula and fastened by means of a LuerLock connector. Therefore within the modular system , a new, absolutely sharp disposable outer cannula is used for every application. In comparison with totally disposable Veress-cannulae, with the same advantages, the modular system offers a large potential to reduce cost.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The indicated patient population is adult, even though there are several studies for pediatric use.
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)
Not Found
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.
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.
K911221, K911202, K911260, K043130, K033018, K012771, K011997, K033249
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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
Veress and Modular Veress Insufflation Cannula
Premarket Notification Submission
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: July 20th, 2006
OCT 1 3 2006
Submitter Information/ production site:
Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-0 Fax: +49(0)7704-9291-610 Establishment Registration Number: 9611612
USA Contact:
Pajunk USA German American Trade Center 5126 South Royal Atlanta Drive 30084 Tucker, Georgia USA
Contact:
Christian Quass, Director Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com
Contact
Stefan Dayagi Fon: +01(0)770-493-9305
E-Mail: stefan.dayagi@pajunk-usa.com
Contract Sterilizer:
SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Mörfelden Germany Tel +49 6105 23091 or +49 (0) 6105 93470 Fax +49 6105 24760
Device Information:
Trade Names: Veress Cannula and Modular Veress Cannula
Common Name: Veress Insufflation Cannula
Classification Name: (reusable) laparoscope, general & plastic surgery
Classification Reference: 21 CfR 876.1500
Poposed Classification: Regulatory Class: II
Proposed Product Code: GCJ, NLM
Review Panel General & Plastic Surgery
Requlation description Endoscopes and accessories
Predicate Devices:
-
- Cannula with sharp obturator & Veress Needle by Karl Storz K800668
-
- Veress Cannula et al. by Richard Wolf Medical K041321
Image /page/0/Picture/32 description: The image contains the number 021. The numbers are black and are on a white background. The numbers are aligned horizontally.
Image /page/0/Picture/33 description: The image shows the logo for PAJUNK Medizintechnologie. Above the logo is the text K062097 and page 1 of 3. The logo is in black and white and features the company name in a bold, sans-serif font.
1
Veress and Modular Veress Insufflation Cannula
Premarket Notification Submission
Image /page/1/Picture/2 description: The image contains the logo for PAJUNK MEDIZINTECHNOLOGIE. There is also some handwritten text that says K062097 and Page 243. The PAJUNK logo is in a black box with white text.
Device Description:
The insufflation cannulae according Veress were developed especially for the safe and efficient r rio moumation oannalae and insufflation cannulae are equipped with maintenance free cocks and a female LuerLock connector. Before application, a sharp outer cannula (sterile packed for modular Veress, reusable for Standard Veress) is mounted onto the reusable inner cannula and fastened by means of a LuerLock connector. Therefore within the modular system , a new, absolutely sharp disposable outer cannula is used for every application. In comparison with totally disposable Veress-cannulae, with the same advantages, the modular system offers a large potential to reduce cost.
Predicate Devices:
The predicate devices are the Veress cannula of Karl Storz (K800668) and the Veress cannula of Richard Wolf (K041321). They are found to be substantially equivalent in intended use, indication and technical characterization.
The Pajunk Veress cannula and the Pajunk modular Veress cannula is found to be as safe and effective as and therefore substantial equivalent to the predicate devices.
The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.
Sterilization
The Insufflation cannula according Veress is supplied non-sterile. It has to be cleaned, disinfected and sterilized before each use by the customer facility according to ist own sterilization protocols.
Cleaning, disinfection and sterilization information for devices supplied non-sterile can be found in section 14.0 of this submission.
The modular insufflation system acc. Veress consists of a sterile sharp outer cannula for skin penetration and a reusable or sterile insufflation cannulal blunt obturator acc. Veress for safe and effective surgical intervention.
The contract sterilizer and the sterilizing process at Sterigenics is the same as that one used for all further Pajunk products already cleared for market in the USA. The Veress cannula is not the worst-case-product which indeed is the Sprotte (K911221, K911202, K911260) and the StimuLong Kit (K043130, K033018) within Pajunks sterilization process.
Packaging and Labeling
The non-sterile Veress insufflation cannula is packaged and labeled just like all the other Pajunks FDA-approved products marketed non-sterile, for example Pajunks Trocar and Balloon Systems K012771 or Pajunks Handles and Electrodes K011997, K033249. Samples and process descriptions for labeling and packaging can be found in section 13.0 and 14.0 of this submission.
Biocompatibility status
All materials employed in the manufacturing process that may come in contact with blood, tissue or fluids to be injected have been cleared in Pajunks former 510(k) applications. Furthermore these materials are long term proven materials for the use with medical devices.
2
Veress and Modular Veress Insufflation Cannula
Premarket Notification Submission
Image /page/2/Picture/2 description: The image contains the logo for PAJUNK MEDIZINTECHNOLOGIE. The logo has the word "PAJUNK" in bold, white letters inside of a black rectangle. Below the rectangle, the word "MEDIZINTECHNOLOGIE" is written in smaller, black letters. There is also some handwritten text to the right of the logo.
Indicated Patient population
The indicated patient population is adult, even though there are several studies for pediatric use.
Technology Characteristics:
The inner and outer cannulas consist of stainless steel. Biocompatibility is proven and documented. The outer cannulas guide cone of the reusable Veress as well as the body of the inner cannula consist of brass while the guide cone/ hub of the disposable cannula consists of inner cannula somala is intended to penetrate the skin. Then the inner cannula is pushed through and spring locked. Now the pneumoperitoneum can be created by insufflation via the inner cannula.
Conclusion:
The comparison between the predicate devices and the proposed devices in section 12 of this submission demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices.
The cannula system acc. Veress has been used for years now. The clinical evaluation and summarizing literature, which is part of this submission 10.0), makes this aspects evident.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top and bottom. Inside the circle is a stylized symbol featuring three curved lines resembling a bird or a wave-like design.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Christian Quass Director of Regulatory Affairs Pajunk GmbH Medizintechnologies Karl-Hall-Str. 1, 78187 Geisingen GERMANY
OCT 1 3 2006
Re: K062097
Trade/Device Name: Veress Cannula and Modular Veress Cannula Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: September 25, 2006 Received: September 27, 2006
Dear Mr. Quass:
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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Protecting and Promoting Public Health.
4
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); good manufacturing practice requirements as set
This letter will allow you to begin marketing your device as described in your Section 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.
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 -
5
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Indications for use
510(k) Number:
Device Name:
Veress cannula and Modular Veress Cannula
Indications for Use:
The Pajunk insufflation cannula acc. Veress and the modular insufflation cannula acc. Veress is employed in minimal invasive surgery. The cannula is designed for the initial puncture with subsequent gas insuffation for laparoscopic operations. It is used to establish a pneumoperitoneum.
Prescription Use X
(Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Legorre
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1