(121 days)
No
The device description focuses on physical enhancements (CornerStone reflectors, NanoLine coating) to improve ultrasound visibility of the needles/cannulas. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a needle/cannula for drug delivery, which is an instrument, not a therapeutic agent itself. Its purpose is to facilitate the administration of therapeutic substances (anesthetics).
No
The devices are cannulas/needles designed for the delivery of anesthetics and analgesics, or to facilitate catheter placement, and are enhanced for ultrasound visibility during these procedures. They are not used to make a diagnosis.
No
The device description clearly states it is a physical medical device consisting of cannulas/needles made of stainless steel tubing and a polycarbonate hub, with a special reflector pattern imprinted on the surface. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the transient delivery of anesthetics for regional anesthesia and analgesia or to facilitate catheter placement. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a needle/cannula used to puncture tissue and inject substances. This is a surgical/procedural tool, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- No mention of analyzing biological samples: IVD devices are designed to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. This device does not perform any such analysis.
The device is a medical device used in a clinical setting for a therapeutic/procedural purpose, not an in vitro diagnostic purpose.
N/A
Intended Use / Indications for Use
The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility -Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono - are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.
Product codes
BSP
Device Description
The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles/ cannulas may be used during all anaesthetic and analgetic procedures according to the physicians indication.
Cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility are standard cannulas/ needles equipped with CornerStone reflectors (cleared in K111374 - SonoPlex STIM) in order to significantly enhance ultrasound visibility.
The cannulas basically consist of stainless steel tubing and an epoxy glued polycarbonate hub. The tubing is optionally coated for better insertion properties with NanoLine, a copolymeric coating cleared for market in K053283.
In order to enhance ultrasound visibility the cannulas are equipped with a special reflector pattern named CornerStone imprinted to the cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.
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
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
The needles/ cannulas have been subjected to standard testing applicable for all cannulas. Standard testing consists of bending stability and breaking resistance testing as well as of hub-to-needle-bondage testing. Due to technological equivalence the subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie. There are no special testing requirements defined, neither in incoming and in-process inspection routines nor in final testing.
Key Metrics
Not Found
Predicate Device(s)
K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
汇||3207 ! Summary of Safety and Effectiveness
Date of Preparation: October 27th 2011
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 Requlatory Affairs, Safety Official
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 USA Contact: PAJUNK MEDICAL SYSTEMS 6611 Bay Circle, Suite 100 Norcross, GA 30071 Phone: (770) 493 - 6832 ext. 111 Fax: (678) 514 - 3388 (770) 330 - 2724 Cell: richard.fischer@pajunk-usa.com
Contact
Contract Sterilizer:
Richard Fischer MD President Fon: +01(0)770-493-6832 Ext 111 Fax: 678 5143388 E-Mail: Richard.fischer@pajunk-usa.com
Device Information:
Device Name:
Trade Names:
Common Name:
Classification Name
Classification Reference
Product Code:
Establishment Registration Number:
Regulatory Class:
Panel:
Predicate Device:
Ethylene Oxide: External service provider, validated procedure.
cannulas/ needles enhanced for ultrasound visibility for anesthesia and analgesia
Tuohy Sono, SonoTAP, Quincke Sono, Chiba Sono and Crawford Sono
Anaesthesia conduction needles/ cannulas
needle, conduction, anesthetic (w/wo introducer)
21 CFR §868.5150, April 1, 2011
BSP
9611612
11
Anesthesiology
K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES PAJUNK® GmbH Medizintechnologie, Geisingen
1
Indications for use
The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility -Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono, Sono and Crawford Sono - are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.
Device Description:
The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles/ cannulas may be used during all anaesthetic and analgetic procedures according to the physicians indication.
Cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility are standard cannulas/ needles equipped with CornerStone reflectors (cleared in K111374 - SonoPlex STIM) in order to significantly enhance ultrasound visibility.
The cannulas basically consist of stainless steel tubing and an epoxy glued polycarbonate hub. The tubing is optionally coated for better insertion properties with NanoLine, a copolymeric coating cleared for market in K053283.
In order to enhance ultrasound visibility the cannulas are equipped with a special reflector pattern named CornerStone imprinted to the cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.
Brand names of the original file as well as the corresponding brand names of the are:
| Predicate: Tuohy | Subject: Tuohy SONO |
|---|---|
| Predicate: Quincke | Subject: Quincke SONO, SonoTAP |
| Predicate: Crawford | Subject: Crawford SONO |
| Predicate: Chiba (Facette) | Subject: Chiba SONO |
Predicate Devices:
Predicate device with identical or at least partial identical indications of use are:
-
- K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES PAJUNK® GmbH Medizintechnologie, Geisingen
The detailed discussion of substantial equivalence can be found in Section 12 of this
- K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES PAJUNK® GmbH Medizintechnologie, Geisingen
submission.
Technological Characteristics:
Tip Specifications
The tips of the needles/ cannulas covered by this 510(k) are identical to the tips of the original predicate devices submission: Tuohy tip, Beveled tip (which is synonymously used with Chiba tip and facette tip), Crawford tip and Quincke tip (SonoTAP).
2
Length
The length of the needles/ cannulas subject to this 510(k) submission are identical to the lengths of the cannulas covered by the predicate device submission.
| Tuohy: | 20mm-180mm |
|---|---|
| Quincke: | 20mm-180mm |
| Chiba: | 20mm-180mm |
| Crawford: | 20mm-180mm |
| Tuohy SONO: | 20mm-180mm |
| Sono TAP, Quincke SONO: | 20mm-180mm |
| Chiba SONO: | 20mm-180mm |
| Crawford SONO: | 20mm-180mm |
Diameters
The diameters of the needles/ cannulas subject to this 510(k) submission are identical to the diameters of the cannulas covered by the predicate device submission.
| Tuohy: 16G - 26G | Tuohy SONO: 16G - 26G |
|---|---|
| Quincke: 16G - 26G | Quincke SONO: 16G - 26G |
| Chiba: 16G - 26G | Sono TAP, Chiba SONO: 16G - 26G |
| Crawford: 16G - 26G | Crawford SONO: 16G - 26G |
Technical specifications
The material of the cannulas/ needles tubing and hub of the predicate devices is identical to the material of the cannulas/ needles tubing and hub of the subject device. So are the glue connections. Both, subject device and predicate device are glued to the hub.
Sterilization
The contract sterilizer and the sterilizing process are identical to the process and sterilizer used for all PAJUNK® - manufactured and purchased devices which are already cleared for market or exempt. Cornerstone-technique does neither influence sterilization process nor shelf life properties.
Cleaning and Sterilization method, which ensures an SAL of 10th as well as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and EtC-residuals as well as shelf life have been validated and are safe and effective.
Efficacy of sterile product's lifecycle has been validated for a period of 10 years now. Shelf life is set to 5 years.
Biocompatibility:
All cannulas comply with ISO 10993-1, 2nd and 30 edition.
The stainless steel tubing of the Sono-needles/cannulas is identical to stainless steel tubing of the NanoLine-needles/cannulas as they were cleared for market in K040965, K000722 and K053283 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
The polycarbonate hub of the Sono-needles/cannulas is identical to the polycarbonate hub of the needles/cannulas as they were cleared for market in K040965, K000722 and K053283 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
3
The epoxy resin glue of the Sono-needles/cannulas is identical to the epoxy resin glue of the needles/cannulas as they were cleared for market in K040965, K000722 and K053283 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
The optional polymeric NanoLine coating of the Sono-needles/cannulas is identical to the polymeric NanoLine coating of the NanoLine-needles/cannulas as they were cleared for market in K053283 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.):
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.
Performance Testing
The needles/ cannulas have been subjected to standard testing applicable for all cannulas. Standard testing consists of bending stability and breaking resistance testing as well as of hubto-needle-bondage testing. Due to technological equivalence the subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie. There are no special testing requirements defined, neither in incoming and in-process inspection routines nor in final testing.
Conclusion:
The comparison between the predicate devices - cannulas for anaesthesia conduction: Tuohy, Quincke. Crawford. Chiba - and the subject device - cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility - 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 the CornerStone -technique is demonstrated for each type of cannula.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Christian G.H. Quass Director Regulatory Affairs Pajunk GmbH Karl-Hall-Strasse 1 Geisingen GERMANY D-78187
FEB 2 9 2012
Re: K113207
Trade/Device Name: Cannulas/ Needles for Anesthesia and Analgesia Enhanced For Ultrasound Visibility
Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: February 15, 2012 Received: February 21, 2012
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 (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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see 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.
5
Page 2 - Mr. Quass
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for use
510(k) Number:
Device Name:
Cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility
Brand name:
Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono
Indications for Use:
The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility -Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono – are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.
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. Schult
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesional, Dental Devices Division of Anesthoolors
510(k) Number. K113207