(91 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a syringe for the loss of resistance technique, with no mention of AI or ML.
No.
The "Intended Use" states that the syringe "is not intended for injection or aspiration," which distinguishes it from devices that might deliver a therapeutic substance or remove fluids for therapeutic purposes. Its sole purpose is to identify the epidural space using the loss of resistance technique.
No
Explanation: The device is a syringe intended for use in the loss of resistance technique to identify the epidural space. While it helps in locating an anatomical space, it does not diagnose a disease, condition, or provide information for detection, diagnosis, or treatment. It is a tool used during a medical procedure, not a diagnostic device.
No
The device description clearly states it is a "sterile finished disposable device" consisting of a "Barrel and Plunger," which are physical hardware components. The intended use and performance studies also focus on the physical characteristics and function of a syringe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in conjunction with an epidural needle tip placement in the epidural space using the loss of resistance technique. This is a procedure performed directly on a patient's body.
- Device Description: The device is a syringe designed for physical manipulation (loss of resistance technique) within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as part of a medical procedure.
N/A
Intended Use / Indications for Use
Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration.
The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
Product codes
CAZ
Device Description
The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. It consists of a barrel and a plunger. It is certified for use with NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. It has a markings area from 0ml to 10ml and a priming volume of 10ml. It is used to identify loss of resistance prior to epidural anaesthesia procedures. The device is made of plastic materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
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 was conducted for the subject device.
Connectivity: LUER and NRFit™ (ISO 80369-6 and ISO 80369-7).
Stability of markings: Complies with internal protocol.
Stability of connectivity during Shelf Life: LUER and NRFit™ (ISO 80369-6 and ISO 80369-7).
Identification of LOR: Complies with internal protocol.
Identification of LOR during Shelf Life: Complies with internal protocol.
The device was tested for Liquid Leakage, Air Leakage, Stress Cracking, Axial Load, Unscrewing torque, Overriding, LOR, Tightness, and Stability Markings at 3 years accelerated aging, 5 years accelerated aging, and 1 year real time aging. All tests passed.
Sterilization validation was done 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.
Shelf life validation tests were performed, including sterility tests and performance tests of essential functions (NRFit and LUER connection, stability of connections) with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years). No decrease in performance was observed after 5 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061737, Busse Loss of Resistance Syringe
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Pajunk GmbH Medizintechnologie Christian Quass Director Regulatory Affairs Karl-Hall-Str. 1 Geisingen, 78187 De
Re: K190345
Trade/Device Name: VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: Class II Product Code: CAZ Dated: April 16, 2019 Received: April 19, 2019
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190345
Device Name
VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7)
Indications for Use (Describe)
Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration.
The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
| 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) |
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3
Image /page/3/Picture/2 description: The image shows the word "PAJUNK" in white letters against a teal background. The letters are bold and sans-serif. There is a small circle with an "R" inside of it to the right of the "K", indicating that the word is a registered trademark.
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2019-05-16
Document Control Number: K190345
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 Cell: (770) 757-2449 Fax: (678) 514-3388 E-Mail: marco.wohnig@pajunk-usa.com
4
Premarket Notification Submission 510(k)
Image /page/4/Picture/1 description: The image features the word "PAJUNK" in bold, white letters against a teal background. The font is sans-serif and appears to be slightly blurred, giving it a soft, diffused look. A small registration mark is visible to the upper right of the letter "K".
Pioneering medical technology
| Device Information: | |
|---|---|
| Device Name: | VPC (Visual Pressure Control) NRFit™ |
| (ISO80369-6) and LUER (ISO80369-7) | |
| 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 | K190345 |
| Classification Name: | conduction, anesthetic |
| Classification Reference: | 21 CFR 868.5140 |
| Product Code: | CAZ |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Predicate Device | K061737, Busse Loss of Resistance Syringe |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) for identification of loss of resistance prior to epidural anaesthesia procedures with either NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7.
The VPC is considered a Class II medical device according to the predicate device as defined in 21 CFR §868.5140, product code CAZ.
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 re-packagers/ medical device manufacturers.
The predicate devices chosen for demonstrating substantial equivalence is the Busse Loss of Resistance Syringe manufactured by ROBERT BUSSE & CO., INC. P.O. BOX 11067 Hauppauge, NY 11788 and cleared by the Food and Drug Administration for market under K061737, product code CAZ, review panel Anaesthesiology.
5
Image /page/5/Picture/1 description: The image shows the word "PAJUNK" in white letters against a teal background. The letters are bold and slightly blurred, giving them a soft appearance. A small registered trademark symbol is visible to the upper right of the letter "K".
Indications for use
Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use.
The loss of Resistance Syringe is not intended for injection or aspiration.
The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
Determination methods and results of Substantial Equivalence Determination:
| Intended Use | Result: Substantially Equivalent |
|---|---|
| Design | Result: Substantially Equivalent |
| Performance | Result: Substantially Equivalent |
Equivalence in materials used
| Characteristics | Predicate device
Busse LOR Syringe
K061737 | Subject Device
VPC (Visual Pressure Control)
NRFit™ (ISO80369-6) and LUER
(ISO80369-7) Loss of Resistance
Syringe | Result of
comparison, if
necessary with
rationale |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Both devices are classified as externally communicating. Therefore, ISO10993-1
biocompatibility applies. | | Substantially equivalent |
| Packaging | Individually sterile in soft blister pouch
or as part of a kit | Individually sterile in soft blister pouch or
as part of a kit | Same packaging
The PAJUNK® individual
packaging was selected
according to a validated
sterilization and
transportation process |
| Indications for
Use | Indication for Use: The Busse Loss of
Resistance Syringe is intended for
use in conjunction with an epidural
needle, to verify the needle tip
placement in the epidural space by
the loss of Resistance technique, it
will be filled with air and/or saline
during use. The loss of Resistance
Syringe is not intended for injection or
aspiration. The Syringe will be sold
sterile individually packaged, and as
part of a sterile kit. | Indication for Use: The VPC (Visual
Pressure Control) NRFit™ (ISO80369-
6) and LUER (ISO80369-7) Loss of
Resistance Syringe is intended for use
in conjunction with an epidural needle,
to verify the needle tip placement in the
epidural space by the loss of Resistance
technique, it will be filled with air and/or
saline during use.
The loss of Resistance Syringe is not
intended for injection or aspiration.
The Syringe will be sold sterile
individually packaged, and as part of a
sterile kit. | identical |
| Overall design: | Barrel, Plunger | Barrel, Plunger | identical
Both devices do not
have direct patient
contact and are made
from plastic materials |
6
Premarket Notification Submission 510(k)
Image /page/6/Picture/1 description: The image shows the word "PAJUNK" in white letters against a teal background. The letters are bold and slightly blurred, giving them a soft appearance. A small circled "R" trademark symbol is located to the right of the "K".
K190345
Pioneering medical technology
| Predicate device | Subject Device | Result of | |
|---|---|---|---|
| Characteristics | Busse LOR Syringe | ||
| K061737 | VPC (Visual Pressure Control) | ||
| NRFit™ (ISO80369-6) and LUER | |||
| (ISO80369-7) Loss of Resistance | |||
| Syringe | comparison, if | ||
| necessary with | |||
| rationale | |||
| Picture | Both systems allow | ||
| easy handling and | |||
| connecting and have a | |||
| smooth plunger for | |||
| LOR-technique | |||
| Materials used | Plastic materials | Plastic materials | identical |
| Each of the materials | |||
| used either in the | |||
| Predicate Devices or | |||
| the Subject Device are | |||
| established materials | |||
| used for manufacturing | |||
| medical devices. | |||
| Connectivity | ISO 80369-7 | ISO 80369-6 NRFit™ | |
| ISO 80369-7 LUER | Both systems do have | ||
| identical connectivity | |||
| towards syringe and | |||
| needle; 2017´s state of | |||
| the art connection type | |||
| is NRFit™ which | |||
| slightly differs in | |||
| dimensions of the male | |||
| and female connectors | |||
| in order to avoid | |||
| misconnections. | |||
| Markings Area | 0ml — 10ml | 0ml — 10ml | identical |
| Priming Volume | 10ml | 10ml | identical |
7
Image /page/7/Picture/1 description: The image features the word "PAJUNK" in bold, white letters against a teal background. The font is sans-serif and appears slightly blurred, giving it a soft, diffused look. A small, superscripted "R" in a circle, indicating a registered trademark, is positioned to the upper right of the letter "K".
Equivalence in the Indications for use
Subject Device:
Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique. it will be filled with air and/or saline during use.
The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
Predicate Devices:
Indication for Use: The Busse Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use.
The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
Discussion
The indications for use as well as the intended use of the predicate devices and of the subject device are identical.
Conclusion: Substantially Equivalent
Sterilization
Subject Device:
Sterilized with Ethylene Oxide. Shelf Life: 5 years.
Predicate Devices:
Sterilized with Ethylene Oxide. Shelf Life: 5 years.
Discussion
Both devices are sterilized using Ethylene Oxide and have a shelf life of 5 years.
Conclusion: Substantially Equivalent
8
Image /page/8/Picture/1 description: The image features the word "PAJUNK" in a bold, sans-serif font. The letters are white, and they stand out against a teal background. The registered trademark symbol is visible to the right of the letter "K".
Performance Testing
Subject Device:
Connectivity: LUER and NRFit™ (ISO 80369-6 and ISO 80369-7). Stability of markings: Complies with internal protocol Stability of connectivity during Shelf Life: LUER and NRFit™ (ISO 80369-6 and ISO 80369-7). Identification of LOR: Complies with internal protocol Identification of LOR during Shelf Life: Complies with internal protocol
Predicate Devices:
Stability of markings: Complies with internal protocol Identification of LOR: Complies with internal protocol
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Image /page/9/Picture/1 description: The image shows the word "PAJUNK" in white letters against a teal background. The letters are slightly blurred, giving them a soft appearance. A small circle with an R inside is located to the right of the K.
Technology Characteristics/ Performance Testing
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% |
| Exposure time | 300 min. |
| Aeration method | evacuation |
| 2 airwashes | |
| Aeration period | residual EtO-gas is removed in circulating |
| air at 40° C (±5) for at least 48h |
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 SAL of 10° 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 of Ethylene oxide and Ethylene chlorohydrin are met.
Limit for Pyrogen/ endotoxin is met.
The VPC is also available in bulk non-sterile. If appropriately packed and sterilized with Ethylene oxide according to the parameters above the technological parameters remain unchanged. However, final responsibility for sterilization remains with the customer of VPC purchased bulk non-sterile.
Shelf Life
Efficacv of sterile product's lifecycle has been validated.
Sterility tests have been performed. Performance of the essential performance of the device (NRFit and LUER connection, stability of connections) has been tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years). There is no decrease in performance after 5 years.
Shelf-life is set to 5 years.
10
Image /page/10/Picture/0 description: The image features the word "PAJUNK" in bold, white letters against a teal background. The font is sans-serif, and the letters are closely spaced, creating a solid block of text. A small circle with an "R" inside, indicating a registered trademark, is positioned to the upper right of the letter "K".
Biocompatibility:
All products comply with ISO 10993-1, 2nd and 3rd edition.
The Subject Device is an external communicating device with no direct patient contact. Therefore, based upon ISO10993-1 biocompatibility is evaluated.
Therefore, and based upon sterilization and residuals validation the devices are considered to be biocompatible.
Standards/ Requirements
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 connectors have been tested:
| Test Detail | Standard | FDA-Rec.-No. | Result |
|---|---|---|---|
| Sterilization | ISO 11135 | 14-452 | Pass |
| Residuals | ISO 10993-7 | 14-408 | Pass |
| Biocompatibility | ISO 10993-1 | 2-220 | Pass |
| Liquid Leakage | ISO 80369-7, 6.1 | 5-115 | Pass |
| Air Leakage | ISO 80369-7, 6.2 | 5-115 | Pass |
| Stress Cracking | ISO 80369-7, 6.3 | 5-115 | Pass |
| Axial Load | ISO 80369-7, 6.4 | 5-115 | Pass |
| Unscrewing torque | ISO 80369-7, 6.5 | 5-115 | Pass |
| Overriding | ISO 80369-7, 6.6 | 5-115 | Pass |
| Liquid Leakage | ISO 80369-6, 6.1 | 5-108 | Pass |
| Air Leakage | ISO 80369-6, 6.2 | 5-108 | Pass |
| Stress Cracking | ISO 80369-6, 6.3 | 5-108 | Pass |
| Axial Load | ISO 80369-6, 6.4 | 5-108 | Pass |
| Unscrewing torque | ISO 80369-6, 6.5 | 5-108 | Pass |
| Overriding | ISO 80369-6, 6.6 | 5-108 | Pass |
| Stability of markings | Internal protocol | n.a. | Pass |
| Identification of LOR | Internal Protocol | n.a. | Pass |
| ISTA Procedure 2A (ASTM D 6653 et al.) | |||
| ASTM F1886 - 09 | |||
| ASTM F 1929 – 98 | |||
| ASTM E 515 – 05 (4a)) | |||
| DIN EN 868-5:2009-09 |
11
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Premarket Notification Submission 510(k)
Pioneering medical technology
| Test Detail | Standard | FDA-Rec.-No. | Result |
|---|---|---|---|
| DIN EN 868-10:2009-09 |
Conclusion:
The comparison between the predicate devices and the subject device of this submission as well as the validated sterilization process and the results of the standard testing and performance testing demonstrates that the subject device is substantially equivalent to the predicate device without raising different questions of safety and effectiveness.
12
PAJUNK®
| Device: VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of
| Resistance Syringe | |||
|---|---|---|---|
| Test Detail | Standard | Level | Result |
| Liquid Leakage | ISO 80369-7, 6.1 | 3 years accelerated aging | Pass |
| Air Leakage | ISO 80369-7, 6.2 | 3 years accelerated aging | Pass |
| Stress Cracking | ISO 80369-7, 6.3 | 3 years accelerated aging | Pass |
| Axial Load | ISO 80369-7, 6.4 | 3 years accelerated aging | Pass |
| Unscrewing torque | ISO 80369-7, 6.5 | 3 years accelerated aging | Pass |
| Overriding | ISO 80369-7, 6.6 | 3 years accelerated aging | Pass |
| LOR | Internal protocol | 3 years accelerated aging | Pass |
| Tightness | Internal Protocol | 3 years accelerated aging | Pass |
| Stability Markings | Internal Protocol | 3 years accelerated aging | Pass |
| Device: VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of
| Resistance Syringe | |||
|---|---|---|---|
| Test Detail | Standard | Level | Result |
| Liquid Leakage | ISO 80369-7, 6.1 | 5 years accelerated aging | Pass |
| Air Leakage | ISO 80369-7, 6.2 | 5 years accelerated aging | Pass |
| Stress Cracking | ISO 80369-7, 6.3 | 5 years accelerated aging | Pass |
| Axial Load | ISO 80369-7, 6.4 | 5 years accelerated aging | Pass |
| Unscrewing torque | ISO 80369-7, 6.5 | 5 years accelerated aging | Pass |
| Overriding | ISO 80369-7, 6.6 | 5 years accelerated aging | Pass |
| LOR | Internal protocol | 5 years accelerated aging | Pass |
| Tightness | Internal Protocol | 5 years accelerated aging | Pass |
| Stability Markings | Internal Protocol | 5 years accelerated aging | Pass |
13
PAJUNK®
| Device: VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of
| Resistance Syringe | |||
|---|---|---|---|
| Test Detail | Standard | Level | Result |
| Liquid Leakage | ISO 80369-7, 6.1 | 1 year real time aging | Pass |
| Air Leakage | ISO 80369-7, 6.2 | 1 year real time aging | Pass |
| Stress Cracking | ISO 80369-7, 6.3 | 1 year real time aging | Pass |
| Axial Load | ISO 80369-7, 6.4 | 1 year real time aging | Pass |
| Unscrewing torque | ISO 80369-7, 6.5 | 1 year real time aging | Pass |
| Overriding | ISO 80369-7, 6.6 | 1 year real time aging | Pass |
| LOR | Internal protocol | 1 year real time aging | Pass |
| Tightness | Internal Protocol | 1 year real time aging | Pass |
| Stability Markings | Internal Protocol | 1 year real time aging | Pass |