(89 days)
Not Found
Not Found
No
The device description and intended use clearly describe a set of manually operated surgical instruments (trocars, sleeves, balloons, etc.) used for creating access and space during laparoscopic procedures. There is no mention of any computational or data-driven components, let alone AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is a surgical tool used for creating access and channels during endoscopic and laparoscopic procedures, not for treating a disease or condition.
No
The device is described as a manually operated surgical device for making incisions, dissecting tissue, and providing instrument channels during endoscopic and laparoscopic procedures. Its function is to facilitate surgical access and procedures, not to diagnose conditions.
No
The device description clearly details physical, manually operated surgical instruments (trocars, sleeves, balloon systems, etc.) used for making incisions and creating surgical spaces. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that this device is a "manually operated surgical device intended for making incisions into the patient's body," "creating a surgical space by dissecting layers of connective tissue," and "providing a well anchored and gas tight instrument channel." These are all procedures performed on the patient's body, not on specimens taken from the body.
- Intended Use: The intended use is for "general endoscopic and laparoscopic procedures," which are surgical procedures performed directly on the patient.
The device is a surgical instrument used for accessing and working within the body during minimally invasive procedures. It does not involve the analysis of biological samples.
N/A
Intended Use / Indications for Use
- Trocar Sleeves: "Manually operated surgical device intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures"
- Trocars: "Manually operated surgical device intended for making incisions into the watient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures"
- Distension System: "Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures"
- Ring-Anchor Balloon System: "Manually operated surgical device intended for providing a well anchored Mandally operatod Calgannel to allow insertion of endoscopes and and light instrument onames to anoval endoscopic and laparoscopic procedures"
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
"The Pajunk Trocars together with the Trocar Sleeves, the Pajunk Balloon Systems and the according accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures. The devices follow the FDA Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology, dated 3/17/95.
Trocar Sleeves
The Paiunk Trocar Sleeves are rigid tubes placed with the help of Trocars or Obturators into the patient's body to allow insertion of endoscopes and endoscopic accessories.
Trocars
The trocars are used together with the trocar sleeves for puncture of the patient's body. The trocar is then removed to allow insertion of endoscopes and endoscopic accessories.
Safety -Trocars
The Pajunk Safety-Trocar features a sharp, beveled tip that is covered by an inside, spring loaded, blunt obturator (Veress-concept). During puncture, the obturator is pushed into the shaft against the force of the spring and thus releases the cutting tip which can now penetrate the skin layers. As soon as the abdominal space is reached, the blunt obturator is moved forward by the spring, covers the cutting tip and prevents injuries in the abdomen.
Distension System
The PAJUNK distension balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where dissection of tissue in the extraperitoneal space under direct view is essential. Contraindications: The distention balloon system should not be used in cases where previous operations in the extraperitoneal space caused adhesions in the area of the extraperitoneal organs.
Structural Balloon System
The PAJUNK structural balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel together with a mechanical support of the extraperitoneal work space is needed. The inflation of the balloon causes a continuing dissection and anchoring in the extraperitoneal work space. Contraindications: The structural balloon system should not be used in cases where previous operations in the extraperitoneal space caused adhesions in the area of the extraperitoneal organs.
Ring-Anchor Balloon System
The PAJUNK Ring-Anchor balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel is needed. Contraindications: The Ring-Anchor balloon system should not be used in cases where previous operations in the extraperitoneal space caused adhesions in the area of the extraperitoneal organs.
Accessories:
Disposable Valve Top
The disposable valve top is used with the Pajunk trocar sleeves and provides the same intended use. The valve is used instead of the trap door valve. The top is made out of polymer instead out of chromated brass. The metal tube is reusable and identical to the ones of the Paiunk trocar sleeves. The advantage is the easier cleaning, sterilization and assembling procedure.
Fixable Slide Cones
The Pajunk fixable slide cones with or without a fixation thread and with suture holders on both sides have been designed for first puncture technique according to Hasson in laparoscopic applications.
Reducer Sleeve
The reducer sleeve is inserted into the actually used trocar sleeve to reduce the diameter for improved quide and gas-tight insertion of endoscopic surgical instruments with outer diameters smaller than the nominal inner diameter of the trocar sleeve.
Dilation Set
If the actually applied trocar sleeve does not provide sufficient space for needed endoscopes and endoscopic accessories or endoscopic surgical instrument it can be replaced with a larger trocar sleeve.
Trocar Stop
The trocar stop with fixation thread is used to fixate the insertion of the trocar sleeve. The trocar sleeve is fixed by hand with a screw."
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
Not Found
Intended User / Care Setting
Physicians / Not specified, implied surgical setting
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.
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
§ 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
Image /page/0/Picture/1 description: The image contains a combination of letters and numbers. The characters "10F" are present, followed by the number "2". The characters appear to be handwritten in a dark ink or marker on a white background. The style of writing is somewhat stylized.
Image /page/0/Picture/2 description: The image shows the word "PAJUNK" in white letters against a black background. The letters are bold and sans-serif. The word is centered in the image and takes up most of the space.
MEDIZINTECHNOLOGIE
NOV 1 4 2001 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
Applicant:
Pajunk GmbH Am Holzplatz 5 - 7 D-78187 Geisingen Germany 07704 9291-0 Tel.
Contact:
Martin Hauger Technical Director
Device Identification:
Common Name: Trocars, Trocar Sleeves
Trade Name: Trocar and Trocar Sleeves, Distension System, Anchoring System
Indication and Device Description: General
The Pajunk Trocars together with the Trocar Sleeves, the Pajunk Balloon Systems and the according accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures. The devices follow the FDA Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology, dated 3/17/95.
Trocar Sleeves
The Paiunk Trocar Sleeves are rigid tubes placed with the help of Trocars or Obturators into the patient's body to allow insertion of endoscopes and endoscopic accessories.
Trocars
The trocars are used together with the trocar sleeves for puncture of the patient's body. The trocar is then removed to allow insertion of endoscopes and endoscopic accessories.
Safety -Trocars
The Pajunk Safety-Trocar features a sharp, beveled tip that is covered by an inside, spring loaded, blunt obturator (Veress-concept). During puncture, the obturator is pushed into the shaft against the force of the spring and thus releases the cutting tip which can now penetrate the skin layers. As soon as the abdominal space is reached, the blunt obturator is moved forward by the spring, covers the cutting tip and prevents injuries in the abdomen.
Distension System
The PAJUNK distension balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where dissection of tissue in the extraperitoneal space under direct view is essential. Contraindications: The distention balloon system should not be used in cases where previous operations in the extraperitoneal space caused adhesions in the area of the extraperitoneal organs.
Structural Balloon System
The PAJUNK structural balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument
1
K012771
2 of 2
Image /page/1/Picture/1 description: The image shows the word "PAJUNK" in white letters against a black background. The letters are bold and sans-serif. The word is centered in the image and takes up most of the space. The image is simple and high contrast.
MEDIZINTECHNOLOGIE
channel together with a mechanical support of the extraperitoneal work space is needed. The inflation of the balloon causes a continuing dissection and anchoring in the extraperitoneal work space. Contraindications: The structural balloon system should not be used in cases where previous operations in the extraperitoneal space caused adhesions in the area of the extraperitoneal organs.
Ring-Anchor Balloon System
The PAJUNK Ring-Anchor balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel is needed. Contraindications: The Ring-Anchor balloon system should not be used in cases where previous operations in the extraperitoneal space caused adhesions in the area of the extraperitoneal organs.
Accessories:
Disposable Valve Top
The disposable valve top is used with the Pajunk trocar sleeves and provides the same intended use. The valve is used instead of the trap door valve. The top is made out of polymer instead out of chromated brass. The metal tube is reusable and identical to the ones of the Paiunk trocar sleeves. The advantage is the easier cleaning, sterilization and assembling procedure.
Fixable Slide Cones
The Pajunk fixable slide cones with or without a fixation thread and with suture holders on both sides have been designed for first puncture technique according to Hasson in laparoscopic applications.
Reducer Sleeve
The reducer sleeve is inserted into the actually used trocar sleeve to reduce the diameter for improved quide and gas-tight insertion of endoscopic surgical instruments with outer diameters smaller than the nominal inner diameter of the trocar sleeve.
Dilation Set
If the actually applied trocar sleeve does not provide sufficient space for needed endoscopes and endoscopic accessories or endoscopic surgical instrument it can be replaced with a larger trocar sleeve.
Trocar Stop
The trocar stop with fixation thread is used to fixate the insertion of the trocar sleeve. The trocar sleeve is fixed by hand with a screw.
Substantial Equivalence:
The Pajunk Trocar and Trocar Sleeves, Distension System, the Anchoring System and accessories are substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Paiunk Trocar and Trocar Sleeves, Distension System, the Anchoring System and accessories and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
K. Haug
Signed:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pajunk GmbH c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
NOV 1 4 2001
Re: K012771
Trade/Device Name: Trocars, Trocar Sleeves, Model 1287; Distension System, Ring-Anchor Balloon System
Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 1, 2001 Received: October 3, 2001
Dear Mr. Job:
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 (PMA), 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.
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 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 - Mr. Mark Job
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Sincerely yours,
for Mark McMullerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K01277/
NOV 1 4 2001
Page ! of
510(k) Number (if known): KO12771
Trocar Sleeves Device Name:
Indications For Use:
Manually operated surgical device intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10,98)
for Mark n Milkersen
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K012771
Gil
5
Page 2 of 4
510(k) Number (if known): KO1277/
Device Name: Trocars
Indications For Use:
Manually operated surgical device intended for making incisions into the watient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Mark-N-Milburn
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number.
6
Page 3 of 4
510(k) Number (if known): KO12771
Device Name: Distension System
Indications For Use:
Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
for Mark N Mikesen
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012
7
Page 4 of 4
510(k) Number (if known): KO12,771
Device Name: Ring-Anchor Balloon System
Indications For Use:
Manually operated surgical device intended for providing a well anchored Mandally operatod Calgannel to allow insertion of endoscopes and and light instrument onames to anoval endoscopic and laparoscopic procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Mark N-Mullenn
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number _
K0(2771