(261 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical characteristics of the needles, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for diagnostic procedures and injection/withdrawal of fluids, not primarily for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic lumbar puncture".
No
The device description explicitly details physical components made of stainless steel and polycarbonate, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to gain entry into or puncture the spinal cavity for injection or withdrawal of fluids for diagnostic lumbar puncture, myelography/discography procedures. While fluid withdrawal is mentioned for diagnostic purposes, the device itself is a tool for accessing the site and collecting the sample, not for performing the diagnostic test on the sample in vitro.
- Device Description: The device is a needle and introducer system. It's a physical tool for accessing the body, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body in vitro.
- Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples in vitro. There's no mention of reagents, assays, or any process that would be performed on a sample outside of the body.
The device is a medical device used for a procedure that may lead to a diagnostic test being performed on a sample collected, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
The SPROTTE® NRFit™, Quincke NRFit™ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures.
The device is intended for adult and pediatric patients.
Product codes
BSP
Device Description
The SPROTTE® NRFit™ and Quincke NRFit™ lumbar puncture needles are disposable devices, supplied sterile to the end user. They are sterilized using Ethylene Oxide. The needles consist of a needle/cannula tubing made of Stainless Steel, a hub made of Polycarbonate, and optionally, glue made of Epoxy resin. An introducer (for SPROTTE® NRFit™) is also present, with tubing made of Stainless Steel, a hub of Polycarbonate, and optional Epoxy resin glue. The stylet (for SPROTTE® NRFit™ and Quincke NRFit™) has tubing made of Stainless Steel and a knob made of Polycarbonate. Some models include a retaining plate and fixation clip made of Polycarbonate. The primary difference between the subject devices and the predicate devices is the design of the hub.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal cavity
Indicated Patient Age Range
adult and pediatric patients
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)
Study Type: Performance Testing, Stability Test (Bonding-to-Hub)
Sample Size: Not specified quantitatively, but comparison of SPROTTE® NRFit™ (9 individual devices ranging from 18G to 29G and 90mm to 150mm length) and SPROTTE® (9 individual devices with similar specifications); Quincke NRFit™ (5 individual devices ranging from 20G to 27G and 80mm to 90mm length) and Quincke (5 individual devices with similar specifications).
Key Results:
- Needle: stability test bending rigidity: The bending rigidity of the predicate device's needles and the subject device's needles is compliant with the standard ISO/FDIS 9626:2016. Conclusion: Substantially Equivalent.
- Needle: stability test bonding to hub: For the needles of the subject device and the needles of the predicate device, a force significantly higher than the target value (≥22N) had to be applied to break the bond between hub and needle tube. Conclusion: Substantially Equivalent.
- Needle: Penetration force: The subject device's needles as well as the predicate device's needles show identical penetration/insertion forces, as per EN 13097. Conclusion: Substantially Equivalent.
- Sterilization: The sterilization parameters (Ethylene Oxide, SAL 10-6, exposure time 300 min, aeration method/period) and validation (ISO 11135-1 Overkill Approach) are identical to predicate devices and are safe and effective.
- Shelf Life: Performance of essential functions (LUER/NRFit™ connection, stability of bonding, needle's bending rigidity) showed no decrease after 5 years, tested with real time aged needles. Conclusion: Shelf-life set to 5 years.
- Biocompatibility: All devices comply with ISO 10993-1, 2nd and 3rd edition. The components of the subject device are identical to the predicate device in formulation, processing, and sterilization. Tests conducted by worst-case device include In vitro Cytotoxicity ISO 10993-5, Irritation ISO 10993-10, Sensitization ISO 10993-10, Acute systemic toxicity, and Hemocompatibility. Conclusion: Devices are considered to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Needle: stability test bonding to hub: acceptance criterion for pull-off force is ≥22N.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
PAJUNK® GmbH Medizintechnologie Christian Quass Director Regulatory Affairs, Safety Officer Karl-Hall-Str. 1 Geisingen, 78187 GERMANY
Re: K160294
Trade/Device Name: SPROTTE® NRFit™ and Quincke NRFit™ lumbar puncture needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: September 19, 2016 Received: September 21, 2016
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. 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) K160294
Device Name
SPROTTE® NRFit™, Quincke NRFit™ lumbar puncture needles
Indications for Use (Describe)
The SPROTTE® NRFit™, Quincke NRFit™ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures.
The device is intended for adult and pediatric patients.
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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Pioneering medical technology
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: October 20th 2016
Document Control Number: K160294
510(k) owner:
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
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
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Pioneering medical technology
| Device Information: | |
|---|---|
| Device Name: | SPROTTE® NRFit™ and Quincke NRFit™ |
| lumbar puncture needles | |
| 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 | K160294 |
| Classification Name: | Anesthesia Conduction Needle |
| Classification Reference: | 21 CFR § 868.5150 |
| Product Code: | BSP |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Predicate Devices: | K911260 |
| (Owner: PAJUNK® GmbH Medizintechnologie) | |
| ATRAUMATIC STANDARD SPROTTE | |
| NEEDLE | |
| K040965 | |
| (Owner: PAJUNK® GmbH Medizintechnologie) | |
| PAJUNK TUOHY NEEDLES, QUINCKE | |
| NEEDLES, CHIBA NEEDLES & CRAWFORD | |
| NEEDLES |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for SPROTTE® NRFit™ and Quincke NRFit™ lumbar puncture needles.
The intended use as well as the basic technical description of the needles which is relevant to clinical use is identical to the predicate devices and has been cleared in 510(k)s sent in earlier by the sponsor.
The clinical technique, the indications for use, the technical specification, the materials used, the sterility status (validation and sterility assurance level) as the biocompatibility status is identical. None of these is affected by the altered hub as it is subject to this submission.
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Pioneering medical technology
1 Identification of Predicate devices
In this section SPROTTE® NRFit™ and Quincke NRFit™ lumbar puncture needles are compared to the predicate device.
In order to avoid confusion and to make the information more readable, the predicate devices shall be identified as Predicate Device I (which is for the SPROTTE® NRFit™) and Predicate Device II (which is for the Quincke NRFit™) since the Subject devices are identical in Indications for use while the predicates show differences in wording.
Predicate Device I
The predicate device for the SPROTTE® NRFit™ lumbar puncture needles is:
- K911260 ATRAUMATIC STANDARD SPROTTE NEEDLE (Owner: PAJUNK® GmbH Medizintechnologie)
Predicate Device II
The predicate device for the Quincke NRFit™ lumbar puncture needles is:
- K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & -CRAWFORD NEEDLES (Owner: PAJUNK® GmbH Medizintechnologie)
Determination methods and results of Substantial Equivalence Determination:
2 Determination of Substantial Equivalence
2.1 Intended Use
Intended Use Subject Device
The SPROTTE® NRFit™, Quincke NRFit™ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures.
The device is intended for adult and pediatric patients.
Intended Use K911260 (Predicate Device I)
To gain entry into or puncture the spinal cavity permitting injection/ withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography and chemonucleolysis procedures.
Intended Use K040965 (Predicate Device II)
Pajunk's anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
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Discussion of differences
For the SPROTTE® NRFit™ lumbar puncture needles the indications for use is exactly the same as in K911260.
For the Quincke NRFit™ lumbar puncture needles the indication for use is covered by the indications for use as given in the predicate K040965.
Rationale: K040965 covers needles for regional anaesthesia (spinal and epidural) and placement of epidural catheters. The Quincke Needle subject to this Premarket Notification is intended for diagnostic lumbar puncture. Instead of injecting agents it is intended for collecting samples of cerebrospinal fluid. The anatomical region of the same. Furthermore Quincke needles (and SPROTTE needles) are state of the art in lumbar puncture for application of anesthetics as well as harvesting spinal fluid. So only the nature of fluid passing through the needle is different, but the anatomical regions are identical. By indicating the needle for collecting of specimens instead of injecting anesthetic agents the risk for the patient especially regarding contamination through fluid path is lowered.
Conclusion: Substantially Equivalent
The predicate device as well as the subject device only differs in design of the hub. This difference does not have any impact on the performance tests listed below due to the fact, that the materials used, the manufacturing processes employed and the techniques described are identical.
2.2 Technical Description
2.2.1 Technical Description SPROTTE
| Materials used in SPROTTE® NRFit™ lumbar puncture needles: | Predicate Device | |||
|---|---|---|---|---|
| NAME OF COMPONENT | MATERIAL | BODY CONTACT | MATERIAL K911260 | |
| 01 | Needle/cannula | |||
| Tubing | Stainless Steel | Direct, limited | Stainless Steel | |
| Hub | Polycarbonate | Indirect, limited | Polycarbonate | |
| Optional: Glue | Epoxy resin | No contact at all | Epoxy resin | |
| 02 | Introducer | |||
| Tubing | Stainless Steel | Direct, limited | Stainless Steel | |
| Hub | Polycarbonate | No contact at all | Polycarbonate | |
| Optional: Glue | Epoxy resin | No contact at all | Epoxy resin | |
| 03 | Stylet | |||
| Tubing | Stainless Steel | Direct, limited | Stainless Steel | |
| Knob | Polycarbonate | No contact at all | Polyamide | |
| Optional: Glue | Epoxy resin | No contact at all | Epoxy resin | |
| 04 | Retaining plate | |||
| Plate | Polycarbonate | No contact at all | Polycarbonate |
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Pioneering medical technology
Based on substantial equivalence testing listed below the following devices are subject to this premarket notification and shall be cleared:
SPROTTE® NRFit™ in a range from 18G to 29G at a rage of length from 50mm to 150mm.
Dimensions cleared in Predicate Device's Premarket Notification 510(k): K911260
Length: 70mm -150mm
Diameter: 19,5G - 24G
Dimensions intended in the subject devices Premarket Notification K160194:
Length: 50mm to 150mm
Diameter: 18G - 29G
12.2.2.1.1 Discussion of differences
-
The material of the hub has been altered in 1994. Before that date Polycarbonate yyy has been used which then was switched to Polycarbonate xxx. The biocompatibility test reports provided for the SPROTTE contain needles equipped with hubs made from xxx. However, the base substance for both is Polycarbonate Medical Grade. Note that yyy has a significant higher flow pattern index.
-
The material of the stylet's knob has been switched from Poliamide to Polycarbonate. Since the knob does not have any patient contact this change is non-significant to form, fit and function.
| Materials used in Quincke NRFit™ lumbar puncture needles: | Predicate Device | ||||
|---|---|---|---|---|---|
| MATERIAL K911260 | MATERIAL | BODY CONTACT | MATERIAL K040965 | ||
| 01 | Needle/ | ||||
| cannula | Tubing | Stainless Steel | Direct, limited | Stainless steel | |
| Hub | Polycarbonate | Indirect, limited | Polycarbonate | ||
| Optional: | |||||
| Glue | Epoxy resin | No contact at all | Epoxy Resin | ||
| 02 | Introducer | Tubing | Stainless Steel | Direct, limited | Stainless steel |
| Hub | Polycarbonate | No contact at all | Polycarbonate | ||
| Optional: | |||||
| Glue | Epoxy resin | No contact at all | Epoxy Resin | ||
| 03 | Stylet | Tubing | Stainless Steel | Direct, limited | Stainless steel |
| Knob | Polycarbonate | No contact at all | Polycarbonate | ||
| Optional: | |||||
| Glue | Epoxy resin | No contact at all | Epoxy Resin |
2.2.2 Technical Description Quincke
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Pioneering medical technology
| Materials used in Quincke NRFit™ lumbar puncture needles: | Predicate Device | ||||
|---|---|---|---|---|---|
| MATERIAL K911260 | MATERIAL | BODY CONTACT | MATERIAL K040965 | ||
| 04 | Retaining | ||||
| plate | Polycarbonate | No contact at all | Polycarbonate | ||
| 05 | Fixation | ||||
| Clip | Polycarbonate | No contact at all | Polycarbonate |
Based on substantial equivalence testing listed below the following devices are subject to this premarket notification and shall be cleared:
Quincke NRFit™ in a range from 20G to 27G at a rage of length from 50mm to 120mm.
Dimensions cleared in Predicate Device's Premarket Notification 510(k): K040965
Length: 35mm – 200mm
Diameter: 14G - 23G
Dimensions intended in the subject devices Premarket Notification K160194:
Length: 25mm – 285mm
Diameter: 20G - 27G
2.2.3 Devices under test
For demonstrating substantial equivalence the items listed below have been compared:
SPROTTE® NRFfit™
| # | Devices/ Materials | Item-number | Length
[mm] | Gauge |
|---|--------------------|-------------|----------------|-------|
| 1 | SPROTTE® NRFit™ | 321163-30F | 120 | 18 |
| 2 | SPROTTE® NRFit™ | 321163-31C | 90 | 19 |
| 3 | SPROTTE® NRFit™ | 321163-31B | 90 | 20 |
| 4 | SPROTTE® NRFit™ | 321163-31A | 90 | 21 |
| 5 | SPROTTE® NRFit™ | 141163-30C | 150 | 22 |
| 6 | SPROTTE® NRFit™ | 131163-30A | 150 | 24 |
| 7 | SPROTTE® NRFit™ | 261163-29A | 150 | 25 |
| 8 | SPROTTE® NRFit™ | 231163-27A | 120 | 27 |
| 9 | SPROTTE® NRFit™ | 501163-28A | 90 | 29 |
SPROTTE®
| # | Devices/ Materials | Item-number | Length
[mm] | Gauge |
|---|--------------------|-------------|----------------|-------|
| 1 | SPROTTE® | 321151-30F | 120 | 18 |
| 2 | SPROTTE® | 321151-31C | 90 | 19 |
| 3 | SPROTTE® | 321151-31B | 90 | 20 |
| 4 | SPROTTE® | 321151-31A | 90 | 21 |
| 5 | SPROTTE® | 141151-30C | 150 | 22 |
| 6 | SPROTTE® | 141151-30A | 150 | 24 |
| 7 | SPROTTE® | 061151-29A | 150 | 25 |
| 8 | SPROTTE® | 231151-27A | 120 | 27 |
| 9 | SPROTTE® | 501151-28A | 90 | 29 |
Quincke NRFit™
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Pioneering medical technology
| # | Devices/ Materials | Item-number | Length
[mm] | Gauge |
|---|--------------------|-------------|----------------|-------|
| 1 | Quincke NRFit™ | 1163-3G080 | 80 | 20 |
| 2 | Quincke NRFit™ | 1163-3E090 | 90 | 22 |
| 3 | Quincke NRFit™ | 1163-7Y090 | 90 | 24 |
| 4 | Quincke NRFit™ | 1163-7C090 | 90 | 25 |
| 5 | Quincke NRFit™ | 1163-7B090 | 90 | 27 |
Quincke
| # | Devices/ Materials | Item-number | Length
[mm] | Gauge |
|---|--------------------|-------------|----------------|-------|
| 1 | Quincke | 1149-3G080 | 80 | 20 |
| 2 | Quincke | 1149-3E090 | 90 | 22 |
| 3 | Quincke | 1149-7Y090 | 90 | 24 |
| 4 | Quincke | 1149-7C090 | 90 | 25 |
| 5 | Quincke | 1149-7B090 | 90 | 27 |
Both, the subject devices as well as the predicate devices have been tested ready to use right after sterilization and have been subject to testing after accelerated aging (1year, 3years, 5years) in order to demonstrate substantial equivalence and Shelf Life.
2.3 Technology/ Performance
2.3.1 Performance Testing: Summary
The predicate device as well as the subject device only differs in design of the hub.
This difference does not have any impact on the performance tests listed below. Therefore performance testing is still valid and applies to both, subject device and predicate device.
Additional benchmark tests of the predicate device and the subject device is not necessary and has not been performed due to the fact, that the materials used, the manufacturing processes employed and the techniques described are identical. Therefore no further benchmark testing is required in order to verify substantial equivalence.
The performance tests have been accomplished in order to comply with the standards listed below (even though 6-366 and 6-362 are not directly linked with Product Code BSP):
| Recognition-# | Standard Number | Title |
|---|---|---|
| 6-366 | ISO 9626 | Stainless steel needle tubing for the manufacture of |
| medical devices - Requirements and test methods | ||
| 6-362 | ISO 7864 | Sterile hypodermic needles for single use - |
| Requirements and test methods | ||
| 5-108 | ISO 80369-6 | Small bore connectors for liquids and gases in |
| healthcare applications - Part 6: Connectors for | ||
| neuraxial applications. |
Stability test Bonding-to-Hub has to be conducted in order to compare the stability of the LUER Hub with the stability of the NRFit™ hub.
Furthermore compliance of the needle hub with ISO 80369-6 has to be proven.
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Pioneering medical technology
Standard testing regarding the remaining sections of the recognized performance standards can be conducted using either the predicate device or the subject device because the needle tubing is identical.
11
PAJUNK®
Needle: stability test bending rigidity
Reason for test: The needle has to demonstrate bending stability and resistance against breakage in order to resist forces reasonably assumed to the needle in situ under the defined intended use
Procedure of test: The test procedure is defined by international standard ISO/FDIS 9626:2016 Stainless steel needle tubing for manufacture of medical devices.
Pass/ Fail criteria: The acceptance criterion of bending rigidity for the cannula is defined in above mentioned standard.
Results: The bending rigidity of the predicate device's needles and the subject device's needles is compliant with the standard.
Conclusion: Substantially Equivalent
Needle: stability test bonding to hub
Reason for test: The needle has to demonstrate stability at the bonding of the hub in order to resist forces reasonably assumed to be applied to the needle in situ under the defined intended use.
Procedure of test: The test procedure is defined by international standard ISO 7864:2016 Sterile hypodermic needles for single use
Pass/ Fail criteria: The acceptance criterion for the bond between hub and needle tube (pull-off force) is ≥22N.
Results: For the needles of the subject device and the needles of the predicate device a force significantly higher than the target value has to be applied. Therefore the predicate device 's needles as well as the subject device 's needles are substantially equivalent.
Conclusion: Substantially Equivalent
Needle: Penetration force
Reason for test: The needles have to demonstrate less trauma when applied with the patient under the intended use. ISO 7864:2016 Sterile hypodermic needles for single use recommends penetration force testing only without giving a normative test method.
Procedure of test: According to international European standard EN 13097.
Pass/ Fail criteria: -none- objective comparison only.
Results: The subject device's needles as well as the predicate device's needles show identical penetration/ insertion forces.
Conclusion: Substantially Equivalent
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2.4 Sterilization
The predicate device as well as the subject device only differs in design of the hub. This difference does not have any impact on Sterilization. Therefore the Sterilization is still valid.
The contract sterilizer and the sterilizing process are identical to the contract sterilizer and the sterilizing process 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 an SAL of 10° as well as compliance with limits for chemical burden, bioburden (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:
The needles are also available in bulk non sterile. If appropriately packed and sterilized with Ethyleneoxide according to the parameters above the technological parameters remain unchanged. However, final responsibility for sterilization remains with the customer of needles purchased bulk non-sterile.
2.5 Shelf Life
The predicate device as well as the subject device only differs in design of the hub. This difference does not have any impact on Shelf Life. Therefore the Shelf Life is still valid.
Efficacy of sterile product´s lifecycle has been validated using similar products and worst case devices.
Sterility tests have been performed using worst case devices with similar characteristics made from identical material after 5 years. The devices were found to be sterile after 5 years, the sterile barrier system is efficient.
Performance of the essential performance of the device (LUER/ NRFit™ connection, stability of bonding connections, catheter's tensile strength, needle 's bending rigidity) has been tested with real time aged needles and catheters made from identical material employing identical processes and those are found to work properly. There is no decrease in performance after 5 years.
Shelf-life is set to 5 years.
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2.6 Biocompatibility:
The predicate device as well as the subject device only differs in design of the hub. The manufacturing processes of the subject device and the predicate device are identical. The difference in design does not have any impact on Biocompatibility of the device. Therefore the biocompatibility testing conducted with the predicate device is still valid.
All devices comply with ISO 10993-1, 2nd and 3rd edition.
The components of the SPROTTE® NRFit™ and Quincke NRFit™ are identical to the components of the SPROTTE and Quincke as they were approved/cleared in K911260 and K040965 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
The components of the subject devices SPROTTE® NRFit™ and Quincke NRFit™ and the components of the predicate devices SPROTTE and Quincke are identical to the components of the worst case device which has been tested in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents, etc.).
The tests listed below have been conducted and accomplished successfully by the worst case device:
- In vitro Cytotoxicity ISO 10993-5
- . Irritation ISO 10993-10
- Sensitization ISO 10993-10
- . Acute systemic toxicity
- . Hemocompatibility
Therefore and based upon sterilization validation and residuals validation the devices are considered to be biocompatible.
3. Conclusion
All tests are passed successfully. There are no significant differences between the baseline and the aged needles Subject device and Predicate device nor are there significant differences between the predicate device and the subject device in performance.
Compliance to international standards and Shelf life of 5 years is proven.
The conclusions drawn from the nonclinical and clinical tests that the device is as safe, as effective, and performs as well as the legally marketed device identified.