(130 days)
No
The description focuses on the physical characteristics of the needle and its enhanced ultrasound visibility through reflectors, with no mention of AI or ML for image analysis or other functions.
No
The device is a needle intended for delivering anesthetics, which are therapeutic agents, but the device itself is a delivery tool, not a therapeutic agent.
No
The device is described as an "anaesthesia conduction needle" intended for the "transient delivery of anesthetics," which is a therapeutic function, not a diagnostic one. While it is used with ultrasound guidance, ultrasound imaging is the diagnostic tool, and the needle itself is for drug delivery.
No
The device description clearly describes a physical medical device (anaesthesia conduction needles) with hardware components and performance testing related to those physical properties.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "transient delivery of anesthetics to provide regional anesthesia and analgesia." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a needle used for injecting substances into the body, guided by ultrasound. This aligns with a medical device used for treatment or intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the SonoTAP and SonoTAP II needles are medical devices used for administering medication, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
Product codes (comma separated list FDA assigned to the subject device)
BSP
Device Description
The subject device, the SonoTAP II needles are single-use anaesthesia conducting needles intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia. The SonoTAP and SonoTAP II needles are intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.
The SonoTAP and SonoTAP II needles is equipped with an injection tube. The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.
The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes.
The SonoTAP and SonoTAP II cannulas are not for intrathecal use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: The needles subject to this premarket submission are subject to performance testing prior to release as well as after shelf life scenario of 5 years.
Tests are performed to comply with ISO 9626, ISO 7864, ISO 80369-6, ISO 80369-7, ISO 80369-20.
Key Results:
ISO 7864 sections tested and passed: 4.3 Cleanliness, 4.4 Limits for acidity or alkalinity, 4.5 Limits for extractable metals, 4.10 Needle Tube, 4.11 Needle point, 4.12 Bond between hub and needle tube, 4.13 Patency of lumen. For 4.12 Bond between hub and needle tube: 69N required, an average of 104,9N and 196,01N met in result.
ISO 9626 sections tested and passed: 5.2 Surface finish and visual appearance, 5.3 Cleanliness, 5.4 Limits for acidity and alkalinity, 5.5 Size designation, 5.6 Dimensions, 5.7 Sample size, 5.8 Stiffness, 5.9 Resistance to breakage, 5.10 Resistance to corrosion.
ISO 80369-6 sections tested: 6.1 Fluid Leakage, 6.2 Air Leakage, 6.3 Stress Cracking, 6.4 Separation Axial Load, 6.5 Unscrewing, 6.6 Overriding.
ISO 80369-7 sections tested: 7.1 Fluid Leakage, 7.2 Air Leakage, 7.3 Stress Cracking, 7.4 Separation Axial Load, 7.5 Unscrewing, 7.6 Overriding.
The sterility assurance level of 10-6 has been successfully validated at both facilities: Sterigenics and HA2.
Both, medical paper and Tyvek have been validated and verified to allow sterilization using EtO and to maintain sterility after a shelf life of 60 month after sterilization.
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.
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.
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
§ 868.5150 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
March 24, 2025
PAJUNK GmbH Medizintechnologie Chiara Meyer Specialist Regulatory Affairs Karl-Hall-Str. 1 Pajunkstr. 1 Geisingen, BW 78187 Germany
Re: K243525
Trade/Device Name: SonoTAP and SonoTAP II Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: February 25, 2025 Received: February 25, 2025
Dear Chiara Meyer:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
SonoTAP and SonoTAP II
Indications for Use (Describe)
The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The letters are a dark green color, and there is a registered trademark symbol to the right of the letter "K". The letter "P" has a white horizontal line going through it.
USA
08 510(k) Summary
Registrations USA
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2025-01-14
Document Control Number: K243525
| 510(k) owner: | PAJUNK® GmbH Medizintechnologie |
|---|---|
| Karl-Hall-Str. 1/ Pajunkstr. 1 | |
| 78187 Geisingen | |
| Baden-Wuerttemberg, Germany | |
| Fon: +49(0)7704-9291-586 | |
| Fax: +49(0)7704-9291-605 | |
| Establishment Registration Number: | |
| 9611612 | |
| Submitter Information/ production site: | PAJUNK® GmbH Medizintechnologie |
| Karl-Hall-Str. 1/ Pajunkstr. 1 | |
| 78187 Geisingen | |
| Baden-Wuerttemberg, Germany | |
| Fon: +49(0)7704-9291-586 | |
| Fax: +49(0)7704-9291-605 | |
| Establishment Registration Number: | |
| 9611612 | |
| Manufacturer/ Submitter Contact: | Christian G. H. Quass |
| Director Regulatory Affairs, Safety Officer | |
| Fon: +49(0)7704-9291-586 | |
| Fax: +49(0)7704-9291-602 | |
| E-Mail: christian.quass@pajunk.com | |
| Alternative Manufacturer/ Submitter Contact: | Chiara Meyer |
| Regulatory Affairs Specialist | |
| Fon: +49(0)7704-9291-627 | |
| Fax: +49(0)7704-9291-602 | |
| E-Mail: chiara.meyer@pajunk.com |
5
510(k)
Premarket Notification Submission
Image /page/5/Picture/2 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The color of the text is a dark green. There is a registered trademark symbol to the right of the letter K.
| USA Contact: | PAJUNK MEDICAL SYSTEMS
4575 Marconi Dr.
Alpharetta, GA 30005
Registration Number: 3004076349
FEI Number*: 3004076349 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| US-Official Correspondent | Marco Wohnig
President
PAJUNK Medical Systems
4575 Marconi Dr.
Alpharetta, GA 30005
Phone: 001-770-4936832
E-Mail: Marco.Wohnig@pajunk-usa.com |
| Contract Sterilizer: | Sterigenics Germany GmbH
Kasteler straße 45
65203 Wiesbaden
Germany, Hessen
Establishment Registration Number: 3002807090 |
| 2nd Contract Sterilizer: | HA2 MEDIZINTECHNIK GMBH
Am Bahndamm 11
Halberstadt Saxony-Anhalt, DE 38820
Registration Number: 3009039068
FEI Number*: 3009039068 |
Device Name and Classification
| Device Name: | SonoTAP und SonoTAP II |
|---|---|
| Premarket Notification Number: | K253525 |
| Classification Name: | Anesthesia Conduction Needle |
| Classification Reference: | 21 CFR § 868.5150 |
| Product Code: | BSP |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
6
Premarket Notification Submission
Image /page/6/Picture/2 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The color of the text is a dark green. A registered trademark symbol is located to the right of the letter "K".
| Sterilization Method: | Ethylene Oxide
disposable device, supplied sterile to the end user and non-sterile
intended to be sterilized prior to use to re-packagers/ medical device
manufacturers |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contract Sterilizer: | Sterigenics Germany GmbH
Kasteler straße 45
65203 Wiesbaden
Germany, Hessen
Establishment Registration Number: 3002807090 |
| Additional Contract Sterilizer: | HA2 MEDIZINTECHNIK GMBH
Am Bahndamm 11
Halberstadt Saxony-Anhalt, DE 38820
Registration Number: 3009039068
FEI Number*: 3009039068 |
Changes to Device: Predicate Device
| Device Name: | SonoTAP, Tuohy SONO |
|---|---|
| Premarket Notification Number: | K113207 |
| Classification Name: | Anesthesia Conduction Needle |
| Classification Reference: | 21 CFR § 868.5150 |
| Product Code: | BSP |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Sterilization Method: | Ethylene Oxide |
| disposable device, supplied sterile to the end user and non-sterile | |
| intended to be sterilized prior to use to re-packagers/ medical device | |
| manufacturers | |
| Contract Sterilizer: | Sterigenics Germany GmbH |
| Kasteler straße 45 | |
| 65203 Wiesbaden | |
| Germany, Hessen | |
| Establishment Registration Number: 3002807090 |
7
Image /page/7/Picture/1 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The color of the text is a dark green. A registered trademark symbol is located to the right of the letter "K".
Changes to Device: Reference Device
| Device Name: | SonoBlock, SonoBlock II |
|---|---|
| Premarket Notification Number: | K241954 |
| Classification Name: | Anesthesia Conduction Needle |
| Classification Reference: | 21 CFR § 868.5150 |
| Product Code: | BSP |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Sterilization Method: | Ethylene Oxide |
| disposable device, supplied sterile to the end user and non-sterile | |
| intended to be sterilized prior to use to re-packagers/ medical device | |
| manufacturers | |
| Contract Sterilizer: | Sterigenics Germany GmbH |
| Kasteler straße 45 | |
| 65203 Wiesbaden | |
| Germany, Hessen | |
| Establishment Registration Number: 3002807090 | |
| Additional Contract Sterilizer: | HA2 MEDIZINTECHNIK GMBH |
| Am Bahndamm 11 | |
| Halberstadt Saxony-Anhalt, DE 38820 | |
| Registration Number: 3009039068 | |
| FEI Number*: 3009039068 |
8
Image /page/8/Picture/1 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The letters are a dark green color, and there is a registered trademark symbol to the right of the letter "K". The background is white.
1 Narrative Device Description
The subject device, the SonoTAP II needles are single-use anaesthesia conducting needles intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia. The SonoTAP and SonoTAP II needles are intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.
The SonoTAP and SonoTAP II needles is equipped with an injection tube. The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.
Image /page/8/Picture/5 description: The image shows a medical device, specifically an epidural catheter. The catheter is a thin, flexible tube with a connector at one end and markings along its length. The markings are evenly spaced and likely indicate depth or distance for insertion. The catheter is coiled at the end.
Figure 1 SonoTAP
Image /page/8/Picture/7 description: The image shows a medical device with a clear tube connected to a yellow connector on one end and a white and black device with a needle on the other end. The clear tube is coiled and appears to be made of plastic. The needle has markings on it, possibly indicating depth or measurement.
Figure 2 SonoTAP II
The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes.
The SonoTAP and SonoTAP II cannulas are not for intrathecal use.
The SonoTAP and SonoTAP II cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.
9
Image /page/9/Picture/1 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The letters are all capitalized and colored in a dark green. A registered trademark symbol is located to the right of the letter K.
2 Determination of Substantial Equivalence
Intended Use Predicate Device (510(K) Predicate)
The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility – Tuohy Sono, Sono, Sono TAP, Quincke Sono, Chiba Sono, SPROTTE® 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.
Intended Use Subject Device
The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
Discussion
The Intended Use of the Predicate device and of the subject device is substantially equivalent. The Subject device as well as the predicate device offers localization via ultrasound as it is state of the art and well established. The Predicate Device additionally offers the facilitation of the placement of a catheter (just Tuohy Sono).
Conclusion: substantially equivalent
3 Technical Description
Substantial Equivalence: Tabulatory Outline
| Characteristi
CS | Subject Device
SonoTAP
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen | Subject Device
SonoTAP II
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen | Predicate Device K113207
SonoTAP
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Picture | Image: SonoTAP needle | Image: SonoTAP II needle | Image: SonoTAP needle |
| Needle
Tubing | Stainless Steel 1.4301 | Stainless Steel 1.4301 | Stainless Steel 1.4301 |
| Tip | Facet; Tuohy | Facet | Facet; Tuohy |
| Characteristics | Subject Device
SonoTAP
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen | Subject Device
SonoTAP II
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen | Predicate Device K113207
SonoTAP
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen |
| Hub | Copolyester (Tritan MX731)
(Indirect Patient Contact) | Lustran/Guardian ABS 348 white
012002 (No Patient Contact) | Copolyester (Tritan MX731)
(Indirect Patient Contact) |
| Coating | Silicone (Dow Corning 360 Medical
Fluid 12500 cSt), Silicone thinner
(Dow Corning Q7-9180 Silicone
Fluid 1.0 cSt) | Silicone (Dow Corning 360 Medical
Fluid 12500 cSt), Silicone thinner
(Dow Corning Q7-9180 Silicone Fluid
1.0 cSt) | Silicone (Dow Corning 360 Medical
Fluid 12500 cSt), Silicone thinner
(Dow Corning Q7-9180 Silicone Fluid
1.0 cSt) |
| US-
enhancement | Cornerstones | Cornerstones | Cornerstones |
| Graduation | Tampapur TPU | Tampapur TPU | Tampapur TPU |
| Bonding
Technology
Needle-to-
Hub | glued | Directly molded | glued |
| Glue | (Epoxy adhesive - Araldite 2011),
alternatively: UV adhesive (Loctite
AA 3921) | n.a. | (Epoxy adhesive - Araldite 2011),
alternatively: UV adhesive (Loctite
AA 3921) |
| Injection tube | PVC (MED7536), PC (HP4) | PVC (MED7536); PVC (RB1); PC
(HP4) | PVC (MED7536); PVC (RB1); PC
(HP4) |
| Diameter | 18G-24G | 21G-24G | 21G-24G |
| Length | 40mm-150mm | 40mm-150mm | 40mm-150mm |
| Connectivity | ISO 80369-7 (LUER) | ISO 80369-6 (NRFit)
ISO 80369-7 (LUER) | ISO 80369-7 (LUER) |
| Packaging | Tyvek, Foil, chromo-duplex board
Alternatively: Paper, Foil | Tyvek, Foil, chromo-duplex board
Alternatively: Paper, Foil | Tyvek, Foil, chromo-duplex board |
| Biocompatibility | Complies with ISO10993-series as required by « Use of International Standard ISO 10993-1, "Biological evaluation
of medical devices - Part 1: Evaluation and testing within a risk management process" », Docket Number : FDA-201
3-D-0350 | | |
| Sterilization
Method | Ethyleneoxide | Ethyleneoxide | Ethyleneoxide |
| Sterility
Assurance
Level | SAL=10-6 | SAL=10-6 | SAL=10-6 |
| Characteristi
cs | Subject Device
SonoTAP
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen | Subject Device
SonoTAP II
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen | Predicate Device K113207
SonoTAP
Manufacturer: PAJUNK® GmbH
Medizintechnologie, Geisingen |
| Sterilization
Service
Provider | Sterigenics, Wiesbaden
HA2 Medizintechnik, Halberstadt | Sterigenics, Wiesbaden
HA2 Medizintechnik, Halberstadt | Sterigenics, Wiesbaden |
| Shelf Life | 60 month from sterilization | 60 month from sterilization | 60 month from sterilization |
10
510(k)
Premarket Notification Submission
Image /page/10/Picture/2 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The letters are all capitalized and colored in a dark green hue. A small, circled "R" symbol is present to the right of the letter "K", indicating a registered trademark.
11
Image /page/11/Picture/1 description: The image shows the logo for PAJUNK. The logo is in a dark green color. The letters are in a sans-serif font and the logo has a registered trademark symbol on the upper right.
Premarket Notification Submission
4 Substantial Equivalence Discussion
The Predicate devices, as well as the subject devices are equipped with ultrasound enhancing cornerstones. Ultrasound position guidance is state of the art. The technique is safe and effective.
The subject device can be either directly injection moulded or glued. Both manufacturing technologies are safe and the processes are running stable. Both technologies are standard technologies.
The predicate devices, the SonoTAP needles, are packed with Tyvek and foil and sterilized with Ethyleneoxide at Sterigenics, Germany.
The subject devices, the SonoTAP II needles, are packed with Tyvek and foil as well as optionally with Medical Paper and foil.
Furthermore, the subject devices are sterilized at Sterigenics in Wiesbaden as well as optionally at HA2 Medizintechnik in Halberstadt.
The main differences which are subject to this premarket submission are
- the addition of a sterilization facility and a)
- b) the addition of an alternative packaging material.
In order to verify substantial equivalence of the sterilization validation validation according ISO 11135 has been performed and successfully accomplished. The sterility assurance level of 10-6 has been successfully validated at both facilities: Sterigenics and HA2.
12
Image /page/12/Picture/1 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The color of the text is a dark green. The letters are closely spaced together, creating a solid block of text. The background is white.
Premarket Notification Submission
In order to verify substantial equivalence of the packaging and shelf life tests have been performed. Both, medical paper and Tyvek have been validated and verified to allow sterilization using EtO and to maintain sterility after a shelf life of 60 month after sterilization.
5 Performance Testing
The needles subject to this premarket submission are subject to performance testing prior to release as well as after shelf life scenario of 5 years.
There is no impact of the change subject to this submission (additional optional sterilization provider, additional optional packaging) on the performance of the needle as defined in the user requirements specification.
Especially the hub to needle bonding requirements remain unaffacted. The processes are still valid and reliable.
The test listed below are standard tests performed on a reqular basis as well as type tests performed after design transfer.
Tests are performed to comply with the international standards listed below in the respectively most current version:
ISO 9626 Stainless steel needle tubing for manufacture of medical devices
ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods
ISO 80369-6 Small bore connectors for liguids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-20 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ISO 9626 defines the quality and properties of the stainless steel tubing remains unaltered and therefore ongoing compliance with this standard remains unaffected by the change. There is no additional/ new risk of breakage or bending.
ISO 80369-series defines the type of connector which also is not affected by the change. The technical equivalency of LUER and NRFit has been verified and cleared in several submissions before and therefore is in compliance. The test reports related to this standard series also do not directly contribute to demonstration of substantial equivalence in this submission. There is no additional risk in this regard.
ISO 7864 defines properties of the needle.
Those properties are not directly linked to the material. Section 4.12 of this standard is directly linked to the stability of the connection of the needle and the risk of detachment oft he needle from the hub. The
13
510(k)
Image /page/13/Picture/1 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The letters are all capitalized and colored in dark green. A small, circled "R" symbol is located to the right of the "K", indicating that the word is a registered trademark. The background is plain white.
Premarket Notification Submission
acceptance criteria have to be met non regarding the material oft he hub and the needle or the type of connection technology. So the test reports for hub-to-needle bondage are required to demonstrate substantial equivalence. The test reports attached to this e-mail subjecting worst case needles demonstrate compliance with the standard (69N required, an average of 104,9N and 196,01N met in result) as well as process stability when manufacturing the needles either with PC Tritan or ABS, either glued or directly moulded.
5.1 ISO 7864
The following sections have been tested:
| section | Pass / Fail |
|---|---|
| 4.3 Cleanliness | Passed |
| 4.4 Limits for acidity or alkalinity | Passed |
| 4.5 Limits for extractable metals | Passed |
| 4.10 Needle Tube | Passed |
| 4.11 Needle point | Passed |
| 4.12 Bond between hub and needle tube | Passed |
| 4.13 Patency of lumen | Passed |
5.2 ISO 9626
The following sections have been tested:
| section | Pass / Fail |
|---|---|
| 5.2 Surface finish and visual appearance | Passed |
| 5.3 Cleanliness | Passed |
| 5.4 Limits for acidity and alkalinity | Passed |
| 5.5 Size designation | Passed |
| 5.6 Dimensions | Passed |
| 5.7 Sample size | Passed |
| 5.8 Stiffness | Passed |
| 5.9 Resistance to breakage | Passed |
| 5.10 Resistance to corrosion | Passed |
14
Image /page/14/Picture/2 description: The image shows the word "PAJUNK" in a bold, sans-serif font. The color of the text is a dark green. A registered trademark symbol is located to the right of the letter "K".
5.3 ISO 80369
The following sections of the 80369-6 have been tested:
| section | |
|---|---|
| 6.1 | Fluid Leakage |
| 6.2 | Air Leakage |
| 6.3 | Stress Cracking |
| 6.4 | Separation Axial Load |
| 6.5 | Unscrewing |
| 6.6 | Overriding |
The following sections of the 80369-7 have been tested:
| section | |
|---|---|
| 7.1 | Fluid Leakage |
| 7.2 | Air Leakage |
| 7.3 | Stress Cracking |
| 7.4 | Separation Axial Load |
| 7.5 | Unscrewing |
| 7.6 | Overriding |
6 Conclusion
The comparison between the predicate device and the subject device of this submission focussed on the validated sterilization process and the shelf life testing demonstrates that the subject device can be optionally in addition packed using medical paper and can be optionally sterilized at the alternative sterilization service provider at an SAL of 10-6.
Based on current in-process testing regularly conducted, safe performance of the SonoTAP II needle is demonstrated.
The results demonstrate that the subject device is substantially equivalent and as safe, as effective, and performs as well as the predicate device.