(88 days)
Not Found
No
The document describes a convenience tray containing standard medical devices for regional anesthesia and makes no mention of AI or ML.
Yes
The device is intended for administering regional anesthesia, which is a medical procedure aimed at alleviating pain or inducing numbness, fitting the definition of a therapeutic device.
No
The device is intended for the administration of regional anesthesia, which is a treatment, not a diagnostic purpose. While it mentions "optional localization via electrical stimulus," this is for guiding the administration of the anesthesia, not for diagnosing a condition.
No
The device description explicitly states it is a "convenience tray" compiled from physical devices (needles, catheters, etc.) and complies with guidance for "Sterilized convenience kits," indicating it is a collection of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "administration of regional anaesthesia to the peripheral plexus". This is a medical procedure performed on a patient's body.
- Device Description: The device is a "convenience tray" containing components used in regional anesthesia procedures. These components are physical devices used for administering medication or facilitating the procedure.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) for a therapeutic procedure.
N/A
Intended Use / Indications for Use
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus continuous is intended for the administration of regional anaesthesia to the peripheral plexus employing continuous technique via catheter, also including optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to support the administration of regional anaethes ia. Neither needle nor catheter is included.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia is intended for the administration of regional anaesthesia to the peripheral plexus, single-shot or continuous technique, optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus single shot is intended for the administration of regional anaesthesia to the peripheral plexus employing single-shot technique also including optional localization via electrical stimulus.
Product codes (comma separated list FDA assigned to the subject device)
CAZ
Device Description
The convenience tray subject to this submission is compiled by customers from devices either cleared by FDA in former 510(k) submissions or exempt to 510(k) clearance procedure. It may contain each one of PAJUNK®'s devices cleared for use in Anaesthesia of the peripheral plexus procedures. The tray complies with FDA's guidance "Sterilized convenience kits". The devices made available for this tray are listed in section 11 of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral plexus
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): 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.
K053283 NanoLine, K013041, K023218, K042979 PlexoLong, K033018, K043130 StimuLong, K062900 StimuLong Tsui Method, StimuLong Sono
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
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
Y082164
Image /page/0/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a dark, textured background. Below this, the word "MEDIZINTECHNOLOGIE" is written in smaller, thinner letters.
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: July 21st 2008
OCT 2 7 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 |
| Contact: |
| Christian G. H. Quass, Director Regulatory |
| Affairs |
| Fon: +49(0)7704-9291-586 |
| Fax: +49(0)7704-9291-605 |
| E-Mail: christian.quass@pajunk.com |
USA Contact:
Pajunk Medical Systems German American Trade Center 5126 South Royal Atlanta Drive 30084 Tucker, Georgia USA
Contact
Stefan Dayagi Fon: +01(0)770-493-9305 E-Mail: stefan.dayagi@pajunk-usa.com
Contract Sterilizer:
- Sterigenics Germany GmbH 2) HA2 Halberstadt
| Device Information: | |
|---|---|
| Device Name: | PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus |
| Trade Names: | StimuLong, PlexoLong, Sono, Several generic, e. g. Basis Set, Spinal Set, Customer Set |
| Common Name: | Convenience Tray for Regional Anesthesia |
| Classification Name: | Kit, conduction anesthesia |
| Classification Reference: | 21CFR868.5140, revised April 1st 2007 |
| Establishment | |
| Registration Number: | 9611612 |
| Regulatory Class: | II |
| Product Code: | CAZ |
| Panel: | Anesthesiology |
| Predicate devices | K053283 NanoLine |
| K013041, K023218, K042979 PlexoLong | |
| K033018, K043130 StimuLong | |
| K062900 StimuLong Tsui Method, StimuLong Sono |
1
Generic Convenience Tray for Regional Anaesthesia
510(k) Premarket Notification Submission
Image /page/1/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a dark, textured background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, lighter letters.
Device Description:
The convenience tray subject to this submission is compiled by customers from devices either cleared by FDA in former 510(k) submissions or exempt to 510(k) clearance procedure. It may contain each one of PAJUNK®'s devices cleared for use in Anaesthesia of the peripheral plexus procedures. The tray complies with FDA's guidance "Sterilized convenience kits".
The devices made available for this tray are listed in section 11 of this submission.
Predicate Devices:
Predicate devices with identical or at least partial indications of use are:
The discussion of substantial eqivalence can be found in Section 12 of this submission.
Sterilization
The contract sterilizer and the sterilizing process is the same as used for all PAJUNK® manufactured and purchased devices which are already cleared for market or exempt and which may be contained in a convenience tray.
Sterilization method, which ensures an SAL of 10° as well as limits for bioburden, pyroburden (i. e. LAL) and EtO-residuals and shelf life have been validated and effective. Efficacy of sterile product's lifecycle has been proven for a periode of 10 years now. Shelf life is set to 5 vears.
Biocompatibility
All devices comply with ISO 10993-1, FDA-modified version also.
Technology Characteristics:
The components are listed in a table in section 11 of this submission. Shelf life and impact of sterilization and storage on the devices has been proven and found to be safe and effective.
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.
The tray components are marketed in similar combinations in Europe for more than ten years now and are safe and effective. Efficacy of manufacturing, tray assembly, sterilization, storage and shelf life has been proven.
2
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christian G. H. Quass Director Regulatory Affairs PAJUNK® GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen GERMANY
OCT 2 7 2008
Re: K082164
Trade/Device Name: PAJUNK® s Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus Continuous
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure Supply
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus: Single Shot
Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: July 29, 2008 Received: July 31, 2008
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act, However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misling a and adulteration.
3
Page 2 - Mr. Quass
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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 the labeling regulation, please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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.dsma/dsmamain.html.
Sincerely yours.
M Samuels-Ferdinand - for //
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
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Indications for use
| 510(k) Number: | |
|---|---|
| Device Name: |
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus continuous
Indications for Use:
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus continuous is intended for the administration of regional anaesthesia to the peripheral plexus employing continuous technique via catheter, also including optional localization via electrical stimulus.
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)
L. Aymond.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
PMN Spinal Convenience Kit R&D Regulatory
Resp. SAG Resp. CQ
5
Image /page/5/Picture/1 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters on a black background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, white letters.
Indications for use
510(k) Number: Device Name:
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply
Indications for Use:
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to support the administration of regional anaethes ia. Neither needle nor catheter is included.
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)
L. Hom
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082169
Page 1 of 1
PMN Spinal Convenience Kit R&D Regulatory
Resp. SAG Resp. CQ
23/134 2008/07/21
6
MEDIZINTECHNOLOGIE
Indications for use
| 510(k) Number: | |
|---|---|
| Device Name: |
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus
Indications for Use:
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia is intended for the administration of regional anaesthesia to the peripheral plexus, single-shot or continuous technique, optional localization via electrical stimulus.
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)
L. Aciamd.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082164
Page 1 of 1
PMN Spinal Convenience Klt R&D Regulatory
Resp. SAG Resp. CQ
7
Image /page/7/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 this, in smaller white letters, is the word "MEDIZINTECHNOLOGIE".
Indications for use
510(k) Number: Device Name:
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus: single shot
Indications for Use:
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus single shot is intended for the administration of regional anaesthesia to the peripheral plexus employing single-shot technique also including optional localization via electrical stimulus.
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 Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082164
Page 1 of 1
PMN Spinal Convenience Kit R&D Regulatory
Resp. SAG Resp. CQ