(38 days)
No
The document describes a mechanical balloon system for surgical dissection and access, with no mention of AI or ML capabilities.
No
The device facilitates laparoscopic surgical procedures and creates a sealed port of access or space for instruments; it does not directly treat a disease or condition.
No
The device is a surgical tool (balloon system and obturator) used for creating and maintaining access during laparoscopic procedures, not for identifying or diagnosing a condition.
No
The device description clearly describes physical components (balloons, obturator, stop cock, fastening device) used in surgical procedures, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in facilitating surgical procedures (laparoscopic access, tissue retraction, tissue separation, establishing a port of access). This is a surgical device used in vivo (within the body).
- Device Description: The description details the physical components and how they are used to create space and maintain access during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The PAJUNK Balloon systems are indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and / or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and / or tissue separation in extraperitoneal procedures, such as in hernia repair.
The PAJUNK Obturator is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
Product codes
GCJ
Device Description
The PAJUNK® Balloon Systems for dilation facilitate safe and effective dissection of the preperitoneal space under direct view. Orientation during minimal invasive procedures is made easier. Three different shaped balloons are available for either unilateral purposes.
The structural balloon is particularly suitable for preperitoneal access. The design of the balloon simplifies the separation of the peritoneum from the abdominal wall. Additionally it prevents the peritoneal space from collapsing in the case of a loss of gas.
The ring-anchor balloon is also suitable for gastight accessing of the preperitoneal space. The seal is made by inflating the ring-anchor balloon and then advancing and securing the fastening device. Insufflation is performed via the built-in stop cock.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity or extraperitoneal space
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
KU906631
APR 1 6 2009
PAJUNK®'s Balloons and Balloon Systems 510(k) Premarket Notification Submission
MEDIZINTECHNOLOGIE
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: December 10th 2008
Submitter Information/ production site:
Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612
USA Contact: Pajunk Medical Systems
German American Trade Center 5126 South Royal Atlanta Drive 30084 Tucker, Georgia USA
Contact:
Christian Quass, Director Regulatory Affairs Patricia Weisbrod, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com E-Mail: patricia.weisbrod@pajunk.com
Contact
Stefan Dayaqi Fon: +01(0)770-493-9305
E-Mail: stefan.dayagi@pajunk-usa.com
Device Information:
Contract Sterilizer: External service provider located in Europe
| Device Name: | PAJUNK®'s Balloons and Balloon systems |
|---|---|
| Trade Names: | PAJUNK®'s Balloons and Balloon systems |
| Common Name: | Balloon Systems for fixation, distension and dilation |
| Classification Name: | laparoscope, general & plastic surgery |
| Classification Reference: | 21 CFR §876.1500, April 1, 2008 |
| Establishment Registration | |
| Number: | 9611612 |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Panel: | General & Plastic Surgery |
| Predicate Devices: | 1. K935426 Preperitoneal Distention Balloon System |
| 2. K973046 Spacemaker surgical Balloon dissector, Spacemake | |
| 3. K042412 Modified Spacemaker system |
PMN Balloon systems
Resp. SAG Resp. CQ
2009/03/06
1
PAJUNK®'s Balloons and Balloon Systems 510(k) Premarket Notification Submission
Image /page/1/Picture/1 description: The image shows the word "PAJUNK" in large, bold, white letters against a black rectangular background. Below the word "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, black letters. The text appears to be a logo or brand name.
: . ' .
.
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ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻮﻧﺲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
1
Device Description:
The PAJUNK® Balloon Systems for dilation facilitate safe and effective dissection of the preperitoneal space under direct view. Orientation during minimal invasive procedures is made easier. Three different shaped balloons are available for either unilateral purposes.
The structural balloon is particularly suitable for preperitoneal access. The design of the balloon simplifies the separation of the peritoneum from the abdominal wall. Additionally it prevents the peritoneal space from collapsing in the case of a loss of gas.
The ring-anchor balloon is also suitable for gastight accessing of the preperitoneal space. The seal is made by inflating the ring-anchor balloon and then advancing and securing the fastening device. Insufflation is performed via the built-in stop cock.
Predicate Devices:
This 510(k) is submitted in order to clarify content of former PMN (K012771) and at the same timme add slightly modified variants. The besic design has been cleared by FDA in K012771.
Predicate devices with identical indications of use are:
-
- K935426 Preperitoneal Distention Balloon System
-
- K973046 Spacemaker surgical Balloon dissector, Spacemaker
-
- K042412 Modified Spacemaker system
The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.
The syringe (30ml) and the ball pump are class I accessories exempt from PMN-process.
Sterilization
The disposable parts are single use, sterilized with EtO. The contract sterilizer and the sterilizing process is the same as that used for all PAJUNK GmbH Medizintechnologie's Products already cleared for market.
The reusable valves and reusable obturators are supplied non-sterile. It is cleared in 510(k) K012771.
Technology Characteristics:
The components are listed in a table in section 11 of this submission.
Conclusion:
The comparison of the predicate devices and the subject device in section 12 of this submission as well as the validated sterilization process and the results of the bench testing and bench marking demonstrates that the proposed devices are substantially equivalent to the predicate devices and identical in technical description to devices already cleared for market and therefore demonstrated to be safe and effective. Based on the clinical evaluation, the biocompatibility testing and the bench testing conducted, safety and effectiveness as well as efficacy of PAJUNK® s balloons and balloon systema for dilation and fixation is proven.
2009/03/06
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pajunk GmbH Medizintechnologie % Ms. Patricia Weisbrod Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen Germany
APR 1 6 2009
Re: K090631
Trade/Device Name: Balloon systems Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 8, 2009 Received: April 6, 2009
Dear Ms. Weisbrod:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Patricia Weisbrod
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PAJUNK®'s Balloons and Balloon Systems 510(k) Premarket Notification Submission
Image /page/4/Picture/1 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, black letters.
Indications for use
510(k) Number: Device Name:
Balloon systems
Indications for Use:
The PAJUNK Balloon systems are indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and / or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and / or tissue separation in extraperitoneal procedures, such as in hernia repair.
The PAJUNK Obturator is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
Prescription Use __
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) 11:16:14
005
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.E. Ogden Luxm
ivision Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K09063
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