(150 days)
Instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.
The Paiunk GmbH Modular Handle Instruments are identical in terms of materials, modes of construction, to the Richard Wolf Medical Modular Forcep and Scissor System.
PAJUNK GmbH Modular Handled Instruments consist of three basic parts: Handles, Guidance Tubes and Instrument Inserts.
Three handles constitute the basis of the system. While the free-moving handle opens and closes without locking into place, the handle with ratchet is especially suitable for securing and holding in place. The combination handle incorporates the advantages of these two handles.
The Guidance Tubes have insulated shafts and include diameter of 3mm (Shaft + Insert = One Unit), 5mm and 10mm.
The instrument inserts consist of four basic types: Grasping Forceps, Scissors, Biopsy Punches and Clamps / Needle Holders.
All handles can be combined with all insulated shafts and instrument inserts, regardless of their size and shape.
The shaft screws onto the handle tightly, and it ensures the safe and secure connection of the two elements. Every module of the handle-instrument is kept in place in its bracing fixture, secured against distortion. A snap-on mechanism locks the instrument insert in the shaft (exception: 3mm tube): This whole clement can then in turn be latched onto the handle by a special locking device. This latching of the connecting rod and the shaft minimizes the torsion stress exerted upon the instrument insert; the double security against distortion transfers the torque also to the entire shaft.
Jacketed with glass fiber-reinforced plastic, the precise mechanical construction of the PAJUNK handle ensures maximum stability.
Designed for left and right handed use, the ergonomically shaped handles are simple and comfortable to operate. The rotary wheel can be adjusted with a little pressure applied by the index finger. A built-in rotation stop secures the desired position when grasping.
The provided documentation does not contain any information regarding acceptance criteria or a study proving that the device meets specific acceptance criteria.
The document is a 510(k) submission for the PAJUNK Modular Handle Instruments, focused on demonstrating substantial equivalence to a predicate device (Richard Wolf Medical, Modular Forcep and Scissor System, K935270).
Here's why the requested information is absent:
- Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics (design, materials, intended use, etc.) and demonstrating that any differences do not raise new questions of safety or effectiveness. It typically does not require the establishment of new, quantitative acceptance criteria or a dedicated study to prove performance against such criteria beyond what was established for the predicate device.
- Focus on Bench Testing and Standards: The "Testing conducted or standards applied to assure safety and effectiveness" section (page 2 of 3) lists compliance with general medical device standards like ISO 11134 (sterilization), ISO 11135 (ethylene oxide sterilization), and ISO 10993 (biocompatibility). These are general safety and performance standards for medical devices, not specific performance criteria for the function of grasping, cutting, or coagulating.
- No Performance Standards Developed: The document explicitly states: "No performance standards have been developed Performance Standards: for this device." This confirms that formal, quantitative performance metrics were not established or tested against for this 510(k).
- No Clinical Trial Information: There is no mention of a clinical trial or even a non-clinical performance study (other than the listed standards compliance) that would involve a test set, ground truth, experts, or statistical analysis of performance outcomes.
Therefore, since the document does not include information on acceptance criteria or a study to meet them, I cannot populate the requested table or answer the specific questions about sample size, data provenance, ground truth, MRMC studies, or standalone performance.
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K033249 (pg i of 3)
SAFETY & EFFECTIVENESS DATA SUMMARY
| Submitters Name, Address & Phone Number: | PAJUNK GmbH |
|---|---|
| Karl-Hall-Str. 1 | |
| D-78187 Geisingen | |
| Germany |
| Submission Correspondent: | Lyle Howard Corporation203 Main Street, PMB 166Flemington, NJ 08822Attention: Lynette Howard |
|---|---|
| Classification Name: | Reusable, Monopolar, Surgical |
| Classification Name: | Reusable, Monopolar, Surgical Instruments |
|---|---|
| Common / Usual Name: | Modular Handle Instruments |
| Proprietary Name: | PAJUNK Modular Handled Instruments |
Establishment Registration Number: 9611612
| Classification: | Class II, Reg. # 876.1500, GCJ, Laparascope, General &Plastic Surgery |
|---|---|
| ----------------- | --------------------------------------------------------------------------- |
No performance standards have been developed Performance Standards: for this device.
Substantial Equivalence:
The PAJUNK Modular Handle Instruments are substantially equivalent to the Richard Wolf Medical, Modular Forcep and Scissor System, K935270 in design, materials, methods of construction and intended use.
The intended use of the devices to which we claim substantial equivalence:
Modular forceps and scissors system for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.
{1}------------------------------------------------
K033249 (pg. 2 of 3)
Testing conducted or standards applied to assure safety and effectiveness include but is not limited to:
ISO 11134 - Sterilization of health care products - Requirements for validation and routine control -- Industrial moist heat sterilization ISO 11135 - Sterilization of health care products - Requirements for validation and routine control - Ethylene oxide sterilization. Biological Evaluation of Medical Devices - ISO 10993-1, ISO 10993-5, ISO 10993-12
Description of the new device:
The Paiunk GmbH Modular Handle Instruments are identical in terms of materials, modes of construction, to the Richard Wolf Medical Modular Forcep and Scissor System.
PAJUNK GmbH Modular Handled Instruments consist of three basic parts: Handles, Guidance Tubes and Instrument Inserts.
Three handles constitute the basis of the system. While the free-moving handle opens and closes without locking into place, the handle with ratchet is especially suitable for securing and holding in place. The combination handle incorporates the advantages of these two handles.
The Guidance Tubes have insulated shafts and include diameter of 3mm (Shaft + Insert = One Unit), 5mm and 10mm.
The instrument inserts consist of four basic types: Grasping Forceps, Scissors, Biopsy Punches and Clamps / Needle Holders.
All handles can be combined with all insulated shafts and instrument inserts, regardless of their size and shape.
The shaft screws onto the handle tightly, and it ensures the safe and secure connection of the two elements. Every module of the handle-instrument is kept in place in its bracing fixture, secured against distortion. A snap-on mechanism locks the instrument insert in the shaft (exception: 3mm tube): This whole clement can then in turn be latched onto the handle by a special locking device. This latching of the connecting rod and the shaft minimizes the torsion stress exerted upon the instrument insert; the double security against distortion transfers the torque also to the entire shaft.
Jacketed with glass fiber-reinforced plastic, the precise mechanical construction of the PAJUNK handle ensures maximum stability.
{2}------------------------------------------------
K033249 (pg 3 of 3)
Designed for left and right handed use, the ergonomically shaped handles are simple and comfortable to operate. The rotary wheel can be adjusted with a little pressure applied by the index finger. A built-in rotation stop secures the desired position when grasping.
Intended Use:
Instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.
Caution: Federal (USA) law restricts this device to sale, distribution, and use by, or on the order of, a physician.
Safety and Efficacy Information:
The Modular Handled Instruments are well recognized as being safe and effective for the stated intended use. The PAJUNK GmbH Modular Handle Instruments have the same operating principals and intended uses as the competitive modular handle instrument systems already in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
PAJUNK GmbH c/o Ms. Lynette Howard Lyle Howard Corporation 203 Main Street, PMB 166 Flemington, New Jersey 08822
Re: K033249
R055249
Trade/Device Name: PAJUNK Modular Handle Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codc: GCJ Dated: February 18, 2004 Received: February 23, 2004
Dear Ms. Howard:
Wc have reviewed your Section 510(k) premarket notification of intent to market the indication indication we nave reviewed your Section 970(x) premained is substantially equivalent (for tinglestions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regally and the Medical Device American so to comments provision to May 20, 1776, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance was a proval application (PMA), and Cosment Act (Act) that do not requent appt o the general controls provisions of the Act. The You may, therefore, manxet the device, sequirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Spccial Controls) or class III (PMA), it If your device is classified (500 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to suell additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase be advised that i Dri 3 hisdance or were complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations and assisted to: registration and listing (21 comply with an the 7te 31equirements, to state manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 807), good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GFR 1800-1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Ms. Lynette Howard
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in you to ough finding of substantial equivalence of your device to a legally premaired 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), please If you deem's specific an arrantiance at (301) 594-4659. 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 other general 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 yours,
Miriam C. Provost
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
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PAJUNK 510(k) K033249 revision (page 64) February 18, 2004 – New FDA Form
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__ PAJUNK Modular Handle Instruments
Indications For Use:
Instruments insulated for optional monopolar coagulation which enable a surgeon to ination manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.
Prescription Use Yes Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Miriam C. Provost
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Page 1 of 1 |
| Division of General, Restorative, | |
| and Neurological Devices |
510(k) Number K033249
く
§ 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.