(214 days)
SonoMSK anesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
The subject device, the SonoMSK needle is a single-use anesthesia conducting needle intended for for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
The SonoMSK needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.
The SonoMSK needle is equipped with an injection tube. The distal connection of the tube is equipped with a LUER Connector according to ISO 80369-7.
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 SonoMSK cannulas are not for intrathecal use.
The SonoMSK cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.
Based on the provided FDA 510(k) Clearance Letter for SonoMSK, here's a detailed description of the acceptance criteria and the study proving the device meets them:
Disclaimer: This document is a 510(k) Summary, not the full submission. Therefore, it focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel performance claims directly against established acceptance criteria for a new type of device. The acceptance criteria described below are primarily related to meeting established international standards for similar devices and ensuring equivalence to the predicate. The "study" largely consists of performance testing against these standards and validation of manufacturing processes (sterilization, packaging, shelf life).
Acceptance Criteria and Device Performance for SonoMSK
The SonoMSK device, as per this 510(k) submission, demonstrates substantial equivalence to its predicate device (SonoTAP) by meeting a series of performance and safety standards, particularly concerning its materials, manufacturing processes (sterilization, packaging), and device characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by compliance with specific sections of recognized international standards for hypodermic needles and connectors. The reported device performance is a "Passed" status for each tested section, indicating compliance with the respective standard's requirements.
| Acceptance Criteria (Standard Section) | Device Performance | Notes |
|---|---|---|
| ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods | ||
| 4.3 Cleanliness | Passed | Ensures the needle is free from debris and contaminants. |
| 4.4 Limits for acidity or alkalinity | Passed | Verifies the pH neutrality of the needle, crucial for patient safety. |
| 4.5 Limits for extractable metals | Passed | Guarantees that no harmful levels of metals leach from the device. |
| 4.10 Needle Tube | Passed | Assesses the integrity and specifications of the needle tubing itself. |
| 4.11 Needle point | Passed | Evaluates the sharpness and integrity of the needle tip. |
| 4.12 Bond between hub and needle tube | Passed | Confirms the strength and stability of the connection between the needle and its hub. |
| 4.13 Patency of lumen | Passed | Ensures the needle's internal passageway is clear and unobstructed for fluid delivery. |
| ISO 9626: Stainless steel needle tubing for manufacture of medical devices | ||
| 5.2 Surface finish and visual appearance | Passed | Verifies the acceptable finish and absence of visible defects. |
| 5.3 Cleanliness | Passed | Confirms the cleanliness of the tubing material prior to assembly. |
| 5.4 Limits for acidity and alkalinity | Passed | Ensures the tubing material is pH neutral. |
| 5.5 Size designation | Passed | Confirms accurate sizing (e.g., gauge) of the needle tubing. |
| 5.6 Dimensions | Passed | Verifies the tubing meets specified dimensional tolerances. |
| 5.7 Sample size | Passed | (Indicates proper sampling for testing, not a performance criterion itself.) |
| 5.8 Stiffness | Passed | Measures the needle's resistance to bending. |
| 5.9 Resistance to breakage | Passed | Assesses the needle's structural integrity against fracture. |
| 5.10 Resistance to corrosion | Passed | Checks the material's durability and resistance to degradation from bodily fluids or other environmental factors. |
| ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | ||
| 7.1 Fluid Leakage | Passed | Ensures the LUER connection prevents fluid escape. |
| 7.2 Air Leakage | Passed | Ensures the LUER connection prevents air ingress/egress. |
| 7.3 Stress Cracking | Passed | Evaluates the hub's resistance to cracking under stress. |
| 7.4 Separation Axial Load | Passed | Tests the force required to pull apart the connection. |
| 7.5 Unscrewing | Passed | Assesses the connection's resistance to accidental loosening. |
| 7.6 Overriding | Passed | Checks that connectors do not bypass intended engagement. |
| Biocompatibility | Complies with ISO 10993-series; meets FDA guidance. | Confirms biological safety; no specific pass/fail values listed, but overall compliance. |
| Sterility Assurance Level (SAL) | 10⁻⁶ | Validated according to ISO 11135-1 (Overkill Approach). |
| Ethylene Oxide (EO) and Ethylene Chlorhydrine (ECH) Residuals | ≤ 25 ppm (25µg/g/device) | Complies with ISO 10993-7. |
| Shelf Life | 60 months (5 years) | Validated based on sterility and performance testing; no decrease in performance or sterile barrier efficiency after 5 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each specific test (e.g., "n=X needles for cleanliness testing"). However, it indicates that testing was performed "on a regular basis as well as type tests performed after design transfer" and "using process most challenging worst case devices."
- Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the referenced ISO standards. For shelf-life testing, "process most challenging worst case devices" were used.
- Data Provenance: The device is manufactured in Geisingen, Germany by PAJUNK GmbH Medizintechnologie. Sterilization is performed at Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The testing itself would have been conducted by the manufacturer or accredited labs in support of the submission, likely within Germany. The data is retrospective, as it covers tests completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission does not involve clinical data or "ground truth" established by expert review in the sense of image interpretation or diagnostic accuracy. The "ground truth" here is adherence to engineering and safety standards (e.g., ISO, component specifications). Compliance is determined by objective measurements against these standards, not subjective expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the basis for "ground truth" is objective measurement against specified international standards, not subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is an anesthesia conduction needle, not an AI-powered diagnostic imaging tool. The submission focuses on demonstrating substantial equivalence in physical characteristics, biocompatibility, sterilization, and basic performance parameters to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. SonoMSK is a physical medical device (anesthesia needle), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" used is defined by the objective requirements and test methods outlined in the cited international standards:
- ISO 7864 (Sterile hypodermic needles for single use)
- ISO 9626 (Stainless steel needle tubing)
- ISO 80369-7 (Small-bore connectors for intravascular or hypodermic applications)
- ISO 10993-series (Biological evaluation of medical devices)
- ISO 11135-1 (Sterilization of health care products - Ethylene oxide)
These standards specify measurable parameters (e.g., dimensions, force, pH limits, sterility levels, residual limits) that the device must meet.
8. The Sample Size for the Training Set
Not applicable. SonoMSK is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
FDA 510(k) Clearance Letter - SonoMSK
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 1, 2025
PAJUNK GmbH Medizintechnologie
Christian Quaß
Director Regulatory Affairs
Karl-Hall-Str. 1
Pajunkstr. 1
Geisingen, BW 78187
Germany
Re: K243690
Trade/Device Name: SonoMSK
Regulation Number: 21 CFR 868.5150
Regulation Name: Anesthesia Conduction Needle
Regulatory Class: Class II
Product Code: BSP
Dated: May 28, 2025
Received: May 28, 2025
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 (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.
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K243690 - Christian Quaß
Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243690 - Christian Quaß
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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,
TING SONG -S
for
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243690
Device Name
SonoMSK
Indications for Use (Describe)
SonoMSK anesthesia 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
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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."
Page 5
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
USA
08 510(k) Summary
Registrations USA
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2025-05-22
Document Control Number: K243690
510(k) Premarket Notification Submission
510(k) SonoMSK
R&D Resp. ELC
Regulatory Resp. CQ/ MCH
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Page 6
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 | SonoMSK |
|---|---|
| Premarket Notification Number | K243690 |
| Classification Name | Anesthesia Conduction Needle |
| Classification Reference | 21 CFR § 868.5150 |
| Product Code | BSP |
| Establishment Registration Number | 9611612 |
| Regulatory Class | II |
| Panel | Anesthesiology |
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510(k) SonoMSK
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Page 7
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
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510(k) SonoMSK
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Page 8
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: 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
510(k) Premarket Notification Submission
510(k) SonoMSK
R&D Resp. ELC
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Page 9
1 Narrative Device Description
The subject device, the SonoMSK needle is a single-use anesthesia conducting needle intended for for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
The SonoMSK needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.
The SonoMSK needle is equipped with an injection tube. The distal connection of the tube is equipped with a LUER Connector according to ISO 80369-7.
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 SonoMSK cannulas are not for intrathecal use.
The SonoMSK cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.
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 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
SonoMSK anesthesia 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 and the predicate device both offer localization via ultrasound as it is state of the art and well established.
510(k) Premarket Notification Submission
510(k) SonoMSK
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Page 10
Conclusion: substantially equivalent
3 Technical Description
Substantial Equivalence: Tabulatory Outline
| Characteristics | Subject Device SonoMSK | Predicate Device K113207 SonoTAP |
|---|---|---|
| Manufacturer: PAJUNK® GmbH Medizintechnologie, Geisingen | Manufacturer: PAJUNK® GmbH Medizintechnologie, Geisingen | |
| Picture | ||
| Needle Tubing | Stainless Steel 1.4301 | Stainless Steel 1.4301 |
| Tip | bevelled tip, bevelled tip with relief grind | Tuohy, Facet |
| Hub | Copolyester (Tritan MX731) (Indirect 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) |
| US-enhancement | Cornerstones | Cornerstone |
| Graduation | Tampapur TPU | Tampapur TPU |
| Bonding Technology Needle-to-Hub | glued | glued |
| Glue | (Epoxy adhesive - Araldite 2011), alternatively: UV adhesive (Loctite AA 3921) | (Epoxy adhesive - Araldite 2011), alternatively: UV adhesive (Loctite AA 3921) |
| Injection tube | PVC (MED7536), PC (HP4), MABS (Terlux 2802) | PVC (MED7536), PC (HP4), MABS (Terlux 2802) |
| Diameter | 22G-27G | 18G - 24G |
510(k) Premarket Notification Submission
510(k) SonoMSK
R&D Resp. ELC
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Page 11
| Characteristics | Subject Device SonoMSK | Predicate Device K113207 SonoTAP |
|---|---|---|
| Manufacturer: PAJUNK® GmbH Medizintechnologie, Geisingen | Manufacturer: PAJUNK® GmbH Medizintechnologie, Geisingen | |
| Length | 25mm-150mm | 40mm - 150 mm |
| Connectivity | ISO 80369-7 (LUER) | ISO 80369-7 (LUER) |
| Packaging | 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-2013-D-0350 | |
| Sterilization Method | Ethyleneoxide | Ethyleneoxide |
| Sterility Assurance Level | SAL=10-6 | SAL=10-6 |
| Sterilization Service Provider | Sterigenics, Wiesbaden HA2 Medizintechnik, Halberstadt | Sterigenics, Wiesbaden |
| Shelf Life | 60 month from sterilization | 60 month from sterilization |
4 Substantial Equivalence Discussion
The predicate device and the subject device have some characteristical differences:
a) tip -> The modified tip of the SonoMSK is designed to enhance visibility under ultrasound and facilitate precise positioning without increasing tissue trauma. Bench testing (needle insertion force and tissue resistance) demonstrated equivalent or reduced insertion forces compared to the predicate. Moreover, the tip design remains within standard clinical geometries used in peripheral nerve block procedures and does not introduce any novel risks.
Therefore, the modified tip does not adversely affect patient safety and maintains effectiveness in achieving targeted nerve access.
b) diameter -> All offered diameters are within commonly used clinical ranges and comply with ISO 9626
510(k) Premarket Notification Submission
510(k) SonoMSK
R&D Resp. ELC
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Page 12
standards for stainless steel needles. The variation in diameter allows customization for specific anatomical approaches (e.g., superficial vs. deep nerves) but does not introduce new risks.
c) length -> The availability of multiple needle lengths allows the clinician to select the appropriate configuration based on patient size, depth of target, and anatomical location. All lengths are within clinically accepted ranges for peripheral and musculoskeletal nerve access and follow design precedents established in similar legally marketed needles.
The predicate devices, the SonoTAP needles, are packed with Tyvek and foil and sterilized with Ethyleneoxide at Sterigenics, Germany.
The subject devices, the SonoMSK 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
a) the addition of a sterilization facility and
b) the addition of an alternative packaging material.
In order to verify substantial equivalence of the sterilization process a sterilization 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.
In order to verify substantial equivalence of the packaging exhaustive 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.
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510(k) SonoMSK
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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 regular 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 80369-7 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
5.1 ISO 7864
The following sections have been tested:
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| 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 |
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5.3 ISO 80369
The following sections of the 80369-7 have been tested:
| section | Pass / Fail |
|---|---|
| 7.1 Fluid Leakage | Passed |
| 7.2 Air Leakage | Passed |
| 7.3 Stress Cracking | Passed |
| 7.4 Separation Axial Load | Passed |
| 7.5 Unscrewing | Passed |
| 7.6 Overriding | Passed |
6 Sterilization
The contract sterilizer and the sterilizing process are identical to the process and sterilizer used for all PAJUNK® - manufactured devices which are already cleared for market or exempt.
Sterilization parameters are:
| SAL | 10-6 |
|---|---|
| Type of gas | Ethylene Oxide 99,99% |
Sterilization has been validated according to ISO 11135-1 Overkill Approach (1 sublethal cycle, 2 half cycle, 1 full cycle)
Residuals of EO and ECH are in compliance with ISO 10993-7.
Cleaning and Sterilization method, which ensures an SAL of 10-6 as well as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and EtO-residuals as well as shelf life have been validated and are safe and effective.
The limits listed below are met by each device:
Limits for Residuals: 25ppm = 25µg/(g/device) of Ehyleneoxide (EO); 25ppm = 25µg/(g/device) Ethylene chlorhydrine
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7 Shelf Life
Efficacy of sterile product´s lifecycle has been validated using process most challenging worst case devices.
Sterility tests have been performed using process most challenging worst case devices with similar characteristics made from the same material after 5 years. The devices were found to be sterile after 5 years, the sterile barrier system is efficient.
Performance of the device (LUER connection, stability of bonding connections, needle´s bending rigidity) has been tested. There is no decrease in performance after 5 years.
Shelf-life is set to 5 years.
8 Biocompatibility
All products comply with ISO 10993-1 and with FDA´s guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Therefore, based on sterilization validation and residuals validation the kits also are considered to be biocompatible.
9 Technology Characteristics
Both, the subject device and the predicate device, consist of identical components.
10 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.
The results demonstrate that the subject device is substantially equivalent and as safe, as effective, and performs as well as the predicate device.
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§ 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).