(94 days)
The Pajunk Epidural MiniFilter NRFit (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.
The Filter is a Class II medical device substantially equivalent to the predicate device (K083451, Portex Epidural Filter) as defined in 21 CFR §868.5130, product code BSN. 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 device is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. It has a flat housing, Female Lock and male connector with rotating locking hub, and a Filter membrane. It is available with either NRFit™ Connector according to ISO 80369-6 or LUER-Connector according to ISO 80369-7.
This document is a 510(k) summary for the PAJUNK Epidural MiniFilter NRFit and LUER, an anesthesia conduction filter. It establishes substantial equivalence to a predicate device (Portex Epidural Filter, K083451). The information provided focuses on the comparative performance with a predicate device and performance against recognized standards, rather than a standalone clinical study with acceptance criteria in the context of diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text, with many fields being "Not Applicable" (N/A) due to the nature of this submission (device performance testing against engineering standards instead of a diagnostic AI study):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Internal Protocol) | Reported Device Performance |
|---|---|
| Sterilization | |
| ISO 11135 | Pass |
| Residuals (ISO 10993-7) | Pass |
| Biocompatibility | |
| ISO 10993-1 | Pass |
| Connectivity | |
| Liquid Leakage (ISO 80369-7, 6.1) | Pass |
| Air Leakage (ISO 80369-7, 6.2) | Pass |
| Stress Cracking (ISO 80369-7, 6.3) | Pass |
| Axial Load (ISO 80369-7, 6.4) | Pass |
| Unscrewing torque (ISO 80369-7, 6.5) | Pass |
| Overriding (ISO 80369-7, 6.6) | Pass |
| Liquid Leakage (ISO 80369-6, 6.1) | Pass |
| Air Leakage (ISO 80369-6, 6.2) | Pass |
| Stress Cracking (ISO 80369-6, 6.3) | Pass |
| Axial Load (ISO 80369-6, 6.4) | Pass |
| Unscrewing torque (ISO 80369-6, 6.5) | Pass |
| Overriding (ISO 80369-6, 6.6) | Pass |
| Filter Performance | |
| Burst Pressure (Internal Protocol) | Pass |
| Bubble Point (Internal Protocol) | Pass |
| Leak Tightness (Internal Protocol) | Pass |
| Flow Rate (Internal Protocol) | Pass (≥ 200ml/Min) |
| Shelf Life | |
| Performance maintained after 5 years (real-time & accelerated aging) | Pass (no decrease in performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes performance testing against engineering standards, not a clinical test set with patient data. Therefore, this information is Not Applicable (N/A) in the context of this submission. The testing was conducted to demonstrate compliance with ISO standards and internal protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is Not Applicable (N/A). The device's performance is gauged against established engineering and biocompatibility standards, not against expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is Not Applicable (N/A) as no expert adjudication of clinical data was involved in this type of device submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is Not Applicable (N/A). This submission is for a physical medical device (anesthesia conduction filter) and does not involve AI or human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable (N/A). This submission is for a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by adherence to recognized international standards (e.g., ISO 80369 series for connectivity, ISO 11135 for sterilization, ISO 10993 for biocompatibility) and internal protocols for specific performance characteristics (Burst Pressure, Bubble Point, Leak Tightness, Flow Rate).
8. The sample size for the training set
This is Not Applicable (N/A). This submission is for a physical medical device and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This is Not Applicable (N/A). No training set for an algorithm was used.
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June 17, 2019
PAJUNK GmbH Medizintechnologie Christian Quass Director Regulatory Affairs, Safety Officer Karl-Hall-Str. 1 78187 Geisingen. Baden-Wuerttemberg, Germany
Re: K190663
Trade/Device Name: Epidural MiniFilter LUER (ISO80369-7), Epidural MiniFilter NRFit (ISO80369-6) Regulation Number: 21 CFR 868.5130 Regulation Name: Anesthesia Conduction Filter Regulatory Class: Class II Product Code: BSN Dated: May 17, 2019 Received: May 20, 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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Todd Courtney Assistant 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190663
Device Name Epidural MiniFilter NRFit (ISO80369-6) and LUER (ISO80369-7)
Indications for Use (Describe)
The Pajunk Epidural MiniFilter NRFit (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.
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: 2019-06-17
Document Control Number: K190663
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
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:
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
Contact
Marco Wohniq President PAJUNK® Medical Systems L.P. Phone: (770) 493-6832 Direct: (470) 448-4070 Cell: (770) 757-2449 (678) 514-3388 Fax: E-Mail: marco.wohnig@pajunk-usa.com
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Image /page/4/Picture/1 description: The image features the word "PAJUNK" in a bold, sans-serif typeface. The letters are white and stand out against a teal background. A small circle with an "R" inside, indicating a registered trademark, is located to the upper right of the letter "K".
| Device Information: | |
|---|---|
| Device Name: | Epidural MiniFilter NRFit™ (ISO80369-6)Epidural MiniFilter LUER (ISO80369-7) |
| Sterilization method: | Ethylene Oxidedisposable device, supplied sterile to the enduser and non-sterile intended to be sterilizedprior to use to repackagers/ medical devicemanufacturers |
| Contract Sterilizer: | Sterigenics Germany GmbHKasteler straße 4565203 WiesbadenGermany, HessenEstablishment Registration Number:3002807090 |
| Document Control Number | K190663 |
| Classification Name: | filter, conduction, anesthetic |
| Classification Reference: | 21 CFR 868.5130 |
| Product Code: | BSN |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Predicate Device | K083451, Portex® Epidural Filter |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for 2 types of Anaesthesia Conduction Filter called Epidural MiniFilter with either NRFit™ Connector according to ISO 80369-6 or LUER-Connector according to ISO 80369-7. The types only differ in shape of the hub.
The Filter is a Class II medical device substantially equivalent to the predicate device (K083451, Portex Epidural Filter) as defined in 21 CFR §868.5130, product code BSN
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 device chosen for demonstrating substantial equivalence is the Portex Epidural Filter manufactured by SMITHS MEDICAL ASD, INC., 10 bowman dr., keene, NH 03431 and cleared by the Food and Drug Administration for market under K083451, product code BSN, review panel Anaesthesiology.
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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 circled R symbol is located to the upper right of the K, indicating a registered trademark.
Indications for use
The Pajunk Epidural MiniFilter NRFit™ (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.
Determination methods and results of Substantial Equivalence Determination:
| Intended Use | Result: Substantially Equivalent |
|---|---|
| Design | Result: Substantially Equivalent |
| Performance | Result: Substantially Equivalent |
| Predicate device | Subject Device | Result of comparison,if necessary withrationale | |
|---|---|---|---|
| Characteristics | K083451 | Anaesthesia Conduction Filter | |
| Biocompatibility | Both devices are classified as externally communicating. Therefore andbased upon ISO10993-1 biocompatibility applies. | Substantially equivalent | |
| Packaging | Individually sterile in soft blisterpouch or as part of a kit | Individually sterile in soft blisterpouch or as part of a kit | Same packagingThe PAJUNK®individual packagingwas selected accordingto a validatedsterilization andtransportation process |
| Indications forUse | An anesthesia conduction filter isa microporous filter used whileadministering to a patientinjections of local anesthetics tominimize particulate (foreignmaterial) contamination of theinjected fluid. | The Pajunk Epidural MiniFilterNRFitTM (ISO80369-6) andEpidural MiniFilter LUER(ISO80369-7) is an anesthesiaconduction filter.An anesthesia conduction filter isa microporous filter used whileadministering to a patientinjections of local anesthetics tominimize particulate (foreignmaterial) contamination of theinjected fluid. | Substantially equivalent |
| Overall design: | Round, flat housingFemale Lock and male connectorwith rotating locking hubFilter membrane | flat housingFemale Lock and male connectorwith rotating locking hubFilter membrane | identicalBoth devices do nothave direct patientcontact and are madefrom plastic materials |
Equivalence in materials used
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Image /page/6/Picture/0 description: The image shows the word "PAJUNK" in white letters against a teal 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 it is a registered trademark.
Pioneering medical technology
| Predicate device | Subject Device | Result of comparison,if necessary withrationale | |
|---|---|---|---|
| Characteristics | K083451 | Anaesthesia Conduction Filter | |
| Picture | Image: Predicate device | Image: Subject Device | Both systems alloweasy handling andconnecting |
| Materials used | Filter housing: Modified AcrylicFilter Media: Supor® 200- 0.2µm(PES) | Filter housing: Modified AcrylicFilter Media: Hydrophilic HI-FLOPES membrane 0.2µm | identicalEach of the materialsused either in thePredicate Devices orthe Subject Device areestablished materialsused for manufacturingmedical devices. |
| Connectivity | ISO 80369-7 | ISO 80369-6 NRFit™ISO 80369-7 LUER | Both systems do haveidentical connectivitytowards syringe andneedle; 2017's state ofthe art connection typeis NRFit™ which slightlydiffers in dimensions ofthe male and femaleconnectors in order toavoid misconnections. |
| Filtration Area | 5,25cm2 | 1,45cm2 | Due to smaller size thesubject devices filtrationarea is smaller. Thefiltration properties i. e.the intended use arenot affected by thisdifference. |
| Flow Rate | ≥ 200ml/Min | ≥ 200ml/Min | identical |
| Bubble Point | ≥ 46psi. | ≥ 46psi. | identical |
Equivalence in the Indications for use
Subject Device:
The Pajunk Epidural MiniFilter NRFit™ (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid.
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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 to be a modern, clean design. A registered trademark symbol is present to the right of the letter "K".
Predicate Devices:
An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid.
Discussion
The indications for use as well as the intended use of the predicate devices and of the subject device are identical. Pajunk's IFU statement is amended by an introducing statement of identify identifying the tradenames for the common term "anaesthesia conduction filter".
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
Performance Testing
Subject Device:
Connectivity: LUER and NRFit™ (ISO 80369-6 and ISO 80369-7). Leak Tightness: Complies with internal protocol Flow Rate: Complies with internal protocol Burst Pressure: Complies with internal protocol Bubble Point: Complies with internal protocol
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Image /page/8/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 rounded. A small registration mark is visible to the upper right of the letter "K".
Pioneering medical technology
Predicate Devices:
Connectivity: LUER (ISO594/ ISO80369-7).
Leak Tightness: Complies with internal protocol of the sponsor
Flow Rate: Complies with internal protocol of the sponsor
Burst Pressure: Complies with internal protocol of the sponsor
Bubble Point: Complies with internal protocol of the sponsor
Technology Characteristics/ Performance Testing
Sterilization
The contract sterilizer and the sterilizing process are identical to the process and sterilizer used for all PAJUNK® - manufactured devices which are already cleared for market or exempt.
Sterilization parameters are
| SAL | 10-6 |
|---|---|
| Type of gas | Ethylene Oxide 99,99% |
| Exposure time | 300 min. |
| Aeration method | evacuation2 airwashes |
| Aeration period | residual EtO-gas is removed in circulatingair 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:
Limits for Residuals of Ehyleneoxide and Ethylene chlorhydrine are met.
Limit for Pyroburden/ endotoxine is met.
The filters 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 filters purchased bulk non-sterile.
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Image /page/9/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 a modern, clean typeface. A registered trademark symbol is present to the right of the letter "K".
Shelf Life
Efficacy 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). There is no decrease in performance after 5 years.
Shelf-life is set to 5 years.
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 and tested.
Biocompatibility has been evaluated and tested according to ISO 10993-1. The tests conducted are testing for Cytotoxicity according to ISO10993-5 and Chemical Analysis and Evaluation according to ISO10993-12. The evaluation and qualification method complies with ISO10993-1 as well as with FDA-2013-D-0350 "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
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 |
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Pioneering medical technology
| Test Detail | Standard | FDA-Rec. -No. | Result |
|---|---|---|---|
| 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 |
| Burst Pressure | Internal protocol | n.a. | Pass |
| Bubble Point | Internal Protocol | n.a. | Pass |
| Leak Tightness | Internal Protocol | n.a. | Pass |
| Flow Rate | 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 | |||
| DIN EN 868-10:2009-09 |
Conclusion:
The comparison between the predicate device and the subject device, 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. The subject device is safe and effective as the legally marketed predicate device.
§ 868.5130 Anesthesia conduction filter.
(a)
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.(b)
Classification. Class II (performance standards).