(47 days)
Pajunk's TrokaBone puncture set consists of a modular system for the extraction of bone and bone marrow samples for histological examinations.
The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.
Pajunk's TrokaBone and TrokaBone Sternal puncture sets consist of a modular system for single and multiple extraction of bone and bone marrow samples. Equipped with an ergonomic handle and manufactured of highgrade stainless steel, TrokaBone shows a high stability.
This looks like a 510(k) premarket notification for a medical device called TrokaBone and TrokaBone Sternal, a biopsy cannula for bone and bone marrow sampling.
The document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
Instead, this submission focuses on establishing substantial equivalence to predicate devices already on the market (K013692 TrapSystem and K051506 Sterylab Bone Biopsy). This is a common pathway for medical devices that are similar in technology and intended use to previously cleared products.
Here's why the requested information about acceptance criteria and performance studies is not present in this document:
- Substantial Equivalence: For 510(k) submissions based on substantial equivalence, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics (materials, design, intended use, sterilization, etc.) and demonstrating that any differences do not raise new questions of safety or effectiveness. It typically does not require extensive clinical performance studies with specific statistical acceptance criteria for the new device as would be seen in a PMA or a de novo submission.
- Device Type: This is a biopsy cannula, which is a relatively low-risk device. Clinical trials to establish performance metrics (like accuracy for a diagnostic device) are generally not required for such devices when a suitable predicate is available. The focus is more on manufacturing quality, sterility, biocompatibility, and functional similarity to existing devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text, as this information is not included in this type of 510(k) submission.
The document primarily states:
- Pajunk's TrokaBone puncture set consists of a modular system for single and multiple extraction of bone and bone marrow samples for histological examinations.
- The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.
- The comparison between the predicate devices and the proposed devices as well as the validated sterilization process demonstrates that the proposed devices are substantially equivalent to the predicate devices and safe and effective.
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TrokaBone, TrokaBone Sternal Premarket Notification Submission
Image /page/0/Picture/1 description: The image shows the text "K070179" at the top, followed by the word "PAJUNK" in a black box. Below the black box, the word "MEDIZINTECHNOLOGIE" is printed. The text appears to be a logo or label for a medical technology company.
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: January 15tt, 2007
4AR 0 7 2007
Submitter Information/ production site:
Pajunk GmbH Medizintechnologie
78187 Geisingen Germany Fon: +49(0)7704-9291-0 Fax: +49(0)7704-9291-605
Karl-Hall-Strasse 01
Contact:
Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com
Contract Sterilizer:
Sterigenics SteriPro Lab & EO Facility
Contact USA
Pajunk USA Stefan Dayagi German American Trade Center 5126 South Royal Atlanta Drive 30084 Tucker, Georgia Fon: +01(0)770-493-9305 E-Mail: stefan.dayagi@pajunk-usa.com
Establishment Registration Number: 9611612
Device Information:
| Device Name: | TrokaBone |
|---|---|
| Trade Name(s): | TrokaBone, TrokaBone Sternal |
| Common Name: | Biopsy cannula |
| Classification Name: | Instrument, Biopsy |
| Classification Reference: | 21 CFR §876.1075, April 1, 2006 |
| Establishment RegistrationNumber: | 9611612 |
| Regulatory Class: | II |
| Product Code: | KNW, FCG |
| Panel: | Gastroenterology/Urology |
| Predicate Devices: | 1. K013692 TrapSystem, manufactured by MDTech1. K051506 Sterylab Bone Biopsy |
ﺴﺴﺴ
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Image /page/1/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, white letters.
Device Description:
Pajunk's TrokaBone and TrokaBone Sternal puncture sets consist of a modular system for single and multiple extraction of bone and bone marrow samples. Equipped with an ergonomic handle and manufactured of highgrade stainless steel, TrokaBone shows a high stability.
Indications for use
Paiunk's TrokaBone puncture set consists of a modular system for the extraction of bone and bone marrow samples for histological examinations.
The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.
Predicate Devices:
Predicate devices with the same indications of use are:
The detailed description of substantial eqivalence outlining relevant parameters can be found in Section 12 of this submission.
Sterilization, Shelf life
Pajunks TrokaBone and TrokaBone Sternal are serilized with EO-gas.
The sterilization process is validated regularly. LAL-Pyrogene-testing, residual testing acc. to ISO10993-7 and bioburden testing are conducted quaterly with differing (worst-case) products.
The contract sterilizer and the sterilizing process is the same as used for all Pajunk Products already cleared for market.
The shelf life is validated for several worst case products (via real time aging) and set to 5 years.
Packaging and Labeling
Packaging and labeling procedures are identical to the procedures employed for several of Pajunks products already cleared for market by the FDA.
Packaging materials (cardboard, tyvek, hardblister) are identical to those employed for several of Pajunks products already cleared for market by the FDA.
Therefore packaging and labeling are claimed to be approved by FDA. Safety and effectiveness have been demonstrated for several years now.
Technology Characteristics:
Pajunk's TrokaBone puncture set consists of a modular system for single and multiple extraction of bone and bone marrow samples. This set offers a high degree of operational comfort during puncture and aspiration. Equipped with an ergonomic handle and manufactured of highgrade stainless steel, TrokaBone distinguishes itself from similar products due to its high stability.
Puncturing of the pelvic crest can be performed with either the bevel (hollow curve) or trocar tip. The puncture cannula is advanced forward into the bone wall by an alternating clockwise / counterclockwise movement under constant pressure. The stylet is removed as soon as the wall has been penetrated and the resistance has diminished.
The outer cannula has a very sharp "wave" shaped tip. With this tip, and a twisting motion, the cannula easily penetrates the inner structure of the tip of the cannula is designed
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TrokaBone, TrokaBone Sternal
Premarket Notification Submission
Image /page/2/Picture/2 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters against a black background. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE".
cylindrically, tapering out towards the forward end. This makes the gathering of the sample and its extraction easier. At the same time, the conical shape ensures that the sample remains unchanged in its structure during tissue retrieval.
The ejection stylet is introduced and advanced into the distal opening of the outer cannula using an introductory aid. The sample can then be extracted.
The use of an inner cannula with biopsy chamber is recommended if more than one biopsy samples are required. This inner cannula takes up the sample during advancement, and it can be retracted for extraction without altering the placement of the outer cannula.
Biocompatibility:
Pajunks TrocaBone consists of materials and components already cleared for market and proven biocompatibility in several tests. Additionally special testing has been conducted for irritation (ISO10993-10), sensitization (ISO10993-10) and cytotoxicity (ISO10993-5) according to ISO10993-1.
Conclusion:
The comparison between the predicate devices and the proposed devices in section 12 of this submission as well as the validated sterilization process demonstrates that the proposed devices are substantially equivalent to the predicate devices and safe and effective.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pajunk GmbH Medizintechnologie % Christian Quass Director Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen Germany
MAR 0 7 2007
Re: K070179
Trade/Device Name: TrokaBone TrokaBone Sternal Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: FCG Dated: February 26, 2007 Received: February 28, 2006
Dear Christian 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 (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
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Page 2 – Christian Quass
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.
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), please contact the Office of Compliance at (240) 276-0115. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkersson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TrokaBone, TrokaBone Sternal Premarket Notification Submission
Image /page/5/Picture/1 description: The image shows the word "PAJUNK" in all capital letters. The letters are white and bolded, and they stand out against a black background. There is a registered trademark symbol to the right of the letter K. The text is centered in the image.
MEDIZINTECHNOLOGIE
| Indications for use |
|---|
| ---------------------------- |
| 510(k) Number: | |
|---|---|
| Device Name: | |
| Indications for Use: |
TrokaBone
Indications for Use:
Pajunk's TrokaBone puncture set consists of a modular system for the extraction of bone and bone marrow samples for histological examinations.
Prescription Use (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)
(Division ign-Off) Division of General, Restorative, and Neuronogical Devices
510(k) Number
Page 1 of 1
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TrokaBone, TrokaBone Sternal Premarket Notification Submission
Image /page/6/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, in smaller white letters, is the word "MEDIZINTECHNOLOGIE".
019
Indications for use
510(k) Number:
Device Name:
TrokaBone Sternal
Indications for Use:
The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.
Prescription Use (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)
Page 1 of 1
PMN TrokaBone
CQ
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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 § 876.9.