(267 days)
K911221 (ATRAUMATIC SPECIAL SPROTTE NEEDLE)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a spinal needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an anaesthesia conduction needle, which is used to deliver anaesthetics, but it does not directly provide a therapeutic effect itself. Its function is to facilitate the administration of a therapeutic agent (anaesthetic).
No
The device is an anaesthesia conduction needle used to apply or provide anaesthesia, and its function involves administering a substance rather than diagnosing a condition.
No
The device description clearly indicates it is a physical medical device (anaesthesia conduction needle) made of materials like Stainless Steel and Polycarbonate, and is available in different gauges and lengths. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to gain entry into the spinal canal for the application of spinal anesthesia and the introduction of a catheter for continuous spinal anesthesia. This is a direct medical intervention on a patient.
- Device Description: The device is a needle designed for physical insertion into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device is clearly intended for a surgical/procedural application within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SPROTTE® SPECIAL NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia.
Product codes
BSP
Device Description
The SPROTTE® Special NRFit™ is an anaesthesia conduction needle. It is a disposable device, supplied sterile to the end user or non-sterile intended to be sterilized prior to use by repackagers/medical device manufacturers. The device is composed of a needle/cannula, introducer, stylet, retaining plate, and haemostylet. The materials used include Stainless Steel 1.4301 (X5CrNi18-10), AISI 304 (V2A) for tubing components, Polycarbonate PC for the hub of the needle and introducer, and the knob of the stylet, and Epoxy resin for optional glue. The subject device differs from its predicate only in 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 canal
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)
Performance testing was conducted to demonstrate substantial equivalence between the subject device (SPROTTE® Special NRFit™) and the predicate device (ATRAUMATIC SPECIAL SPROTTE NEEDLE K911221). The tests focused on areas not impacted by the altered hub design, which is the only difference between the devices.
Study Types:
- Needle: stability test bending rigidity: This test assesses the needle's ability to resist bending and breakage.
- Needle: stability test bonding to hub: This test evaluates the strength of the bond between the hub and the needle tube.
- Needle: Penetration force: This test compares the force required for needle penetration.
Sample Size:
For the substantial equivalence testing, the following devices were compared:
- Subject devices under test: 5 items (SPROTTE® Special NRFit™) across various item-numbers, lots, lengths (90mm, 100mm), and gauges (18, 19, 21, 22, 24).
- Predicate devices under test: 5 items (SPROTTE® Special) across various item-numbers, lots, lengths (90mm, 100mm), and gauges (18, 19, 21, 22, 24).
Both subject and predicate devices were tested ready to use after sterilization and after accelerated aging (1 year, 3 years, 5 years) to demonstrate shelf life.
Key Results:
- Needle: stability test bending rigidity: The bending rigidity of both the predicate device's needles and the subject device's needles was found to be compliant with ISO/FDIS 9626:2016. Conclusion: Substantially Equivalent.
- Needle: stability test bonding to hub: For both the subject device and predicate device needles, a force significantly higher than the target pull-off force of ≥22N (as per ISO/FDIS 7864:2016) was required. Conclusion: Substantially Equivalent.
- Needle: Penetration force: The subject device's needles and the predicate device's needles showed identical penetration/insertion forces based on EN 13097. Conclusion: Substantially Equivalent.
Sterilization Validation: Sterilization has been validated according to ISO 11135-1 Overkill Approach (1 sublethal cycle, 2 half cycle, 1 full cycle) ensuring a SAL of 10-6. Residuals of EO and ECH comply with ISO 10993-7.
Shelf Life Validation: Efficacy of the sterile product's lifecycle validated using similar products and worst-case devices. Sterility tests performed on worst-case devices after 5 years showed they remained sterile. Performance of essential device features (LUER/NRFit™ connection, bonding stability, catheter's tensile strength, needle's bending rigidity) tested with real-time aged needles and catheters showed no decrease in performance after 5 years. Shelf-life is set to 5 years.
Biocompatibility Testing: All devices comply with ISO 10993-1, 2nd and 3rd edition. Tests conducted successfully include: In vitro Cytotoxicity ISO 10993-5, Irritation ISO 10993-10, Sensitization ISO 10993-10, Acute systemic toxicity, and Hemocompatibility.
Overall Conclusion: All tests were passed successfully. No significant differences were found between the baseline and aged needles, nor between the predicate and subject devices in performance. Compliance to international standards and a shelf life of 5 years is proven. The device is considered as safe, as effective, and performs as well as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K911221 (ATRAUMATIC SPECIAL SPROTTE NEEDLE)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2016
PAJUNK® GmbH Medizintechnologie Christian Quass Director Regulatory Affairs Karl-hall-str. 1 Geisingen, 78187 DE Germany
Re: K160296
Trade/Device Name: SPROTTE® Special NRFit™ Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: September 22, 2016 Received: September 27, 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
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Indications for Use
510(k) Number (if known) K160296
Device Name SPROTTE® Special NRFit™
Indications for Use (Describe)
The SPROTTE® SPECIAL NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia.
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 27th 2016
Document Control Number: K160296
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 Requlatory 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 Wohniq 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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| Device Information: | |
|---|---|
| Device Name: | SPROTTE® Special NRFit™™ |
| 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 | K160296 |
| 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: | K911221 |
| ATRAUMATIC SPECIAL SPROTTE NEEDLE | |
| Owner: PAJUNK® GmbH Medizintechnologie |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for SPROTTE® Special NRFit™ needles for spinal anaesthesia.
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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Predicate Device
The predicate device for the SPROTTE® SPECIAL NRFit™ Anaesthesia conduction needle is:
- K911221 ATRAUMATIC SPECIAL SPROTTE NEEDLE (Owner: PAJUNK® GmbH -Medizintechnologie)
12.2 Determination of Substantial Equivalence
12.2.1 Intended Use
Intended Use Subject Device
The SPROTTE® SPECIAL NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia.
Intended Use K911221 (Predicate Device)
This needle is intended to gain entry into the spinal canal. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia.
Discussion of differences
For the SPROTTE® SPECIAL NRFit™ needle the indications for use is exactly the same as for the predicate device.
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 absolutely identical.
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Pioneering medical technology
12.2.2 Technical Description
12.2.2.1 Technical Description SPROTTE Special
| Materials used in SPROTTE® Special NRFit™ spinal anaesthesia needles: | Predicate Device | ||||
|---|---|---|---|---|---|
| NAME OF COMPONENT | MATERIAL | BODY CONTACT | MATERIAL K911221 | ||
| 01 | Needle/ | ||||
| cannula | Tubing | Stainless Steel 1.4301 | |||
| (X5CrNi18-10), AISI 304 | |||||
| (V2A) | Direct, limited | Stainless Steel 1.4301 | |||
| (X5CrNi18-10), AISI 304 | |||||
| (V2A) | |||||
| Hub | Polycarbonate PC - | Indirect, limited | Polycarbonate PC | ||
| Ramp in | |||||
| tip | Polycarbonate PC - | Indirect, limited | Epoxy resin | ||
| Optional: | |||||
| Glue | Epoxy resin | No contact at all | Epoxy resin | ||
| 02 | Introducer | Tubing | Stainless Steel 1.4301 | ||
| (X5CrNi18-10), AISI 304 | |||||
| (V2A) | Direct, limited | Stainless Steel 1.4301 | |||
| (X5CrNi18-10), AISI 304 | |||||
| (V2A) | |||||
| Hub | Polycarbonate PC - | No contact at all | Polycarbonate PC | ||
| Optional: | |||||
| Glue | Epoxy resin | No contact at all | Epoxy resin | ||
| 03 | Stylet | Tubing | Stainless Steel 1.4301 | ||
| (X5CrNi18-10), AISI 304 | |||||
| (V2A) | Direct, limited | Stainless Steel V2A | |||
| Knob | Polycarbonate PC | No contact at all | Poliamide | ||
| Optional: | |||||
| Glue | Epoxy resin | No contact at all | Epoxy resin | ||
| U | |||||
| 04 | Retaining | ||||
| plate | Plate | Polycarbonate PC - | No contact at all | Polycarbonate | |
| 05 | Haemostylet | stylet | Stainless Steel 1.4301 | ||
| (X5CrNi18-10), AISI 304 | |||||
| (V2A) | Direct, limited | Stainless Steel V2A |
Based on substantial equivalence testing listed below the following devices are subject to this premarket notification and shall be cleared:
SPROTTE® Special NRFit™ in a range from 18G to 24G at a rage of length from 90mm to 100mm.
Dimensions cleared in Predicate Device's Premarket Notification 510(k): K911221
Length: 90mm -103mm
Diameter: 22G – 24G
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12.2.2.1.1 Discussion of differences
-
The material of the hub has been altered in 1994. Before that date Polycarbonate PC xxx has been used which then was switched to Polycarbonate PC - yyy. The biocompatibility test reports provided for the SPROTTE contain needles equipped with hubs made from yyy. However, the base substance for both is Polycarbonate Medical Grade. xxx has a significant higher flow pattern index.
-
The material of the stylet´s knob has been switched from Poliamide zzz to Polycarbonate PC yyy. Since the knob does not have any patient contact this change is non-significant to form, fit and function.
12.2.2.3 Devices under test
For demonstrating substantial equivalence the items listed below have been compared:
Subject devices under test
| # | Devices/ Materials | Item-number | LOT | Length
[mm] | Gauge |
|---|-------------------------|-------------|------|----------------|-------|
| 1 | SPROTTE® Special NRFit™ | 0011163-54 | 1116 | 90 | 18 |
| 2 | SPROTTE® Special NRFit™ | 0001163-54 | 1116 | 90 | 19 |
| 3 | SPROTTE® Special NRFit™ | 0051163-55 | 1116 | 100 | 21 |
| 4 | SPROTTE® Special NRFit™ | 0061163-55 | 1116 | 100 | 22 |
| 5 | SPROTTE® Special NRFit™ | 0071163-54 | 1116 | 90 | 24 |
Predicate devices under test
| # | Devices/ Materials | Item-number | LOT | Length [mm] | Gauge |
|---|---|---|---|---|---|
| 1 | SPROTTE® Special | 0011151-54 | 1116 | 90 | 18 |
| 2 | SPROTTE® Special | 0001151-54 | 1116 | 90 | 19 |
| 3 | SPROTTE® Special | 0051151-55 | 1116 | 100 | 21 |
| 4 | SPROTTE® Special | 0061151-54 | 1116 | 100 | 22 |
| 5 | SPROTTE® Special | 0071151-54 | 1116 | 90 | 24 |
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.
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12.2.3 Technology/ Performance
12.2.3.1 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.
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.
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 absolutely identical.
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
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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/FDIS 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/FDIS 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
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.
| 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.
Sterilization parameters are
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Premarket Notification Submission 510(k)
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Pioneering medical technology
Cleaning and Sterilization method, which ensures an SAL of 10th as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL and the rabbit pyrogen test) and EtOresiduals as well as shelf life have been validated.
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 vears.
Shelf-life is set to 5 years.
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 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.
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Premarket Notification Submission 510(k)
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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 tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified.