(149 days)
Not Found
No
The device description focuses on a mechanical pressure limiting mechanism and a manometer for pressure monitoring. There is no mention of AI, ML, or any computational analysis of data.
No.
The device primarily monitors and limits injection pressure for safety during peripheral nerve blocks, rather than directly treating a disease or condition itself. Its function is to prevent unsafe injections by stopping flow, which is a safety mechanism, not a therapeutic action.
No
The device is a pressure limiter that measures injection pressure and prevents unsafe injections by limiting that pressure. While it monitors pressure, its primary function is to prevent harm and guide the user in repositioning the needle, rather than to diagnose a condition.
No
The device description clearly indicates it is a physical, disposable manometer with mechanical components (valve, locking mechanism) that connects between a needle and syringe to measure and limit injection pressure. It is not software.
Based on the provided information, the NerveGuard Nerve Block Injection Pressure Limiter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NerveGuard's Function: The NerveGuard device directly interacts with the patient during a medical procedure (peripheral nerve block administration). It measures and limits the pressure of the injection into the patient's body. It does not analyze or test any specimen taken from the patient's body.
- Intended Use: The intended use clearly states it's for "measuring injection pressure during administration of peripheral nerve blocks." This is a procedural aid, not a diagnostic test performed on a specimen.
Therefore, the NerveGuard falls under the category of a medical device used in a clinical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
Product codes (comma separated list FDA assigned to the subject device)
BSP, CAZ
Device Description
The NerveGuard NRFit and NerveGuard LUER are single use sterile devices.
The NerveGuard NRFit and NerveGuard LUER are packed in a soft blister package.
The procedure requires connection to a needle intended for peripheral neve block and an injection device, typically a 10/20ml syringe (not subject to this 510(k)).
The NerveGuard is attached between the hub of the needle and the syringe via male and female connector.
Upon starting injection the pressure is monitored while the needle is inserted into the patients' skin. When exceeding the maximum pressure the NerveGuard limits the injection pressure. The user can slightly release force and proceed injection beyond the limitation value.
The NerveGuard pressure monitor is a disposable manometer for objective monitoring of injection pressure during administration of peripheral nerve blocks (PNB). Monitoring opening injection pressure with the NerveGuard helps identify unsafe injections before they start. When the NervGuard measures high opening injection pressure and limits this pressure down to a maximum of 18Psi. the needle can be repositioned and the injection resumed.
Usually the operator creates a force on the plunger (Fo) on the filled syringe which leads to normal flow of anesthetic through a valve in the NerveGuard. At this time, the resistance force of the locking mechanism Fs is higher when Fo. The locking mechanism closes the valve as soon as the force Fo overshoots Fs. The flow is stopped immediately. The NerveGuard will prevent a flow of anesthetic and fullfill it's protective function. Upon release of pressure Fo the valve reopens and the procedure can move on.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Subject Device has been tested to comply with the state-of-the-art standards listed below. For connector standards both, the male and female connector have been tested:
- Sterilization: ISO 11135, Result: Pass
- Residuals: ISO 10993-7, Result: Pass
- Biocompatibility: ISO 10993-1, Result: Pass
- Liquid Leakage: ISO 80369-7, 6.1, Result: Pass
- Air Leakage: ISO 80369-7, 6.2, Result: Pass
- Stress Cracking: ISO 80369-7, 6.3, Result: Pass
- Axial Load: ISO 80369-7, 6.4, Result: Pass
- Unscrewing torque: ISO 80369-7, 6.5, Result: Pass
- Overriding: ISO 80369-7, 6.6, Result: Pass
- Liquid Leakage: ISO 80369-6, 6.1, Result: Pass
- Air Leakage: ISO 80369-6, 6.2, Result: Pass
- Stress Cracking: ISO 80369-6, 6.3, Result: Pass
- Axial Load: ISO 80369-6, 6.4, Result: Pass
- Unscrewing torque: ISO 80369-6, 6.5, Result: Pass
- Overriding: ISO 80369-6, 6.6, Result: Pass
- Accuracy of measuring: Internal protocol, Result: Pass
- Compatibility LUER: Internal Protocol, Result: Pass
- Compatibility NRFit: Internal Protocol, Result: Pass
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.
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
§ 868.5150 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
July 12, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
PAJUNK GmbH Medizintechnologie Christian Quass Director Regulatory Affairs, Safety Officer Karl-Hall-Str. 1 78187 Geisingen, Germany
Re: K170435
Trade/Device Name: NerveGuard NRFit, NerveGuard LUER Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP, CAZ Dated: June 14, 2017 Received: June 16, 2017
Dear Christian Quass:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.
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
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark S. Fellman -S
for
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170435
Device Name NerveGuard NRFit NerveGuard LUER
Indications for Use (Describe)
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image features the word "PAJUNK" in bold, white letters against a teal background. The font is sans-serif and appears to be a custom typeface. A registered trademark symbol is located to the right of the letter "K".
Pioneering medical technology
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2017-07-12
Document Control Number: K170435
510(k) owner:
PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen, Baden-Wuerttemberg, Germany
Establishment Registration Number: 9611612
Submitter Information/ production site:
PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, 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, Safety Officer Patricia Weisbrod Regulatory Affairs Manager 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 140 Norcross, GA 30071 Phone +1 (888) 9PAJUNK (72-5865) Fax +1 (678) 514-3388
Establishment Registration Number: 3004076349
Contact
Marco Wohnig President PAJUNK® Medical Systems L.P. Phone: (770) 493-6832 Direct: (470) 448-4070 (770) 757-2449 Cell: Fax: (678) 514-3388 E-Mail: marco.wohnig@pajunk-usa.com
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K170435
Pioneering medical technology
| Device Information: | |
|---|---|
| Device Name: | NerveGuard NRFit |
| NerveGuard LUER | |
| Sterilization method: | Ethylene Oxide |
| disposable device, supplied sterile to the end | |
| user and non-sterile intended to be sterilized | |
| prior to use to repackagers/ medical device | |
| manufacturers | |
| Contract Sterilizer: | Sterigenics Germany GmbH |
| Kasteler straße 45 | |
| 65203 Wiesbaden | |
| Germany, Hessen | |
| Establishment Registration Number: | |
| 3002807090 | |
| Document Control Number | K170435 |
| Classification Name: | Anesthetic conduction needle |
| Classification Reference: | 21 CFR 868.5150 |
| Product Codes: | BSP, CAZ |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Predicate Device by competitor | K031128 |
| B-Smart |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the NerveGuard with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7.
Substantial equivalence is based on a competitor´s device.
The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/ medical device manufacturers.
5
Image /page/5/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and sans-serif. A small circle with an R inside is located to the right of the K, indicating that the word is a registered trademark.
Indications for use
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
Device Description/ Principle of operation
The NerveGuard NRFit and NerveGuard LUER are single use sterile devices.
The NerveGuard NRFit and NerveGuard LUER are packed in a soft blister package.
The procedure requires connection to a needle intended for peripheral neve block and an injection device, typically a 10/20ml syringe (not subject to this 510(k)).
The NerveGuard is attached between the hub of the needle and the syringe via male and female connector.
Upon starting injection the pressure is monitored while the needle is inserted into the patients' skin. When exceeding the maximum pressure the NerveGuard limits the injection pressure. The user can slightly release force and proceed injection beyond the limitation value.
The NerveGuard pressure monitor is a disposable manometer for objective monitoring of injection pressure during administration of peripheral nerve blocks (PNB). Monitoring opening injection pressure with the NerveGuard helps identify unsafe injections before they start. When the NervGuard measures high opening injection pressure and limits this pressure down to a maximum of 18Psi. the needle can be repositioned and the injection resumed.
Usually the operator creates a force on the plunger (Fo) on the filled syringe which leads to normal flow of anesthetic through a valve in the NerveGuard. At this time, the resistance force of the locking mechanism Fs is higher when Fo. The locking mechanism closes the valve as soon as the force Fo overshoots Fs. The flow is stopped immediately. The NerveGuard will prevent a flow of anesthetic and fullfill it's protective function. Upon release of pressure Fo the valve reopens and the procedure can move on.
Determination methods and results of Substantial Equivalence Determination:
| Intended Use | Result: Substantially Equivalent |
|---|---|
| Comparison of outer appearance and assemblies | Result: Substantially Equivalent |
| Accuracy test | Result: Substantially Equivalent |
| Stability of needle/ manometer connector | Result: Substantially Equivalent |
6
Image /page/6/Picture/0 description: The image shows the word "PAJUNK" in white letters on a green background. The letters are bold and sans-serif. There is a registered trademark symbol after the K.
Equivalence in materials used and design
| | Predicate device | Subject Device | Result of
comparison, if
necessary with
rationale |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | K031128 | NerveGuard | |
| | B-Smart
MACOSTA MEDICAL | Pajunk® GmbH
Medizintechnologie | |
| Biocompatibility | Both devices are external communicating. Therefore and based upon
ISO10993-1 biocompatibility applies. | | Substantially
equivalent |
| Packaging | Individually packed and sterilized or
as set component.
Single sterile in medical paper bag
(heat sealed) | Individually packed and sterilized
or as set component.
Single sterile in Tyvek bag (heat
sealed)
As a set component packed in a
rigid tray, wrapped and packaged
in a soft blister pack (heat sealed). | Same packaging
The PAJUNK®
individual packaging
was selected
according to a
validated sterilization
and transportation
process |
| Intended Use | The Macosta Medical B-Smart
Nerve Block Injection Pressure
Manometer is a disposable
manometer for measuring injection
pressure during administration of
peripheral nerve blocks. | The NerveGuard Nerve Block
Injection Pressure Limiter is a
disposable manometer for
measuring injection pressure
during administration of peripheral
nerve blocks. | Substantially
equivalent |
| Overall design: | Materials: plastics
No direct patient contact | Materials: Polycarbonate, HDPE
No direct patient contact | Both devices do not
have direct patient
contact and are made
from plastic materials |
| Picture | Image: white pressure meter | Image: green pressure meter | Both systems allow
easy handling and
connecting |
| connectivity | Distal connector:male
Proximal connector: female | Distal connector: male
Proximal connector: female | Both systems do
have identical
connectivity towards
syringe and needle |
| Capacity | Indicates pressure with a cylindrical
hub | Indicates pressure and limits
pressure to 20psi red | Limits injection to