(281 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The performance studies described are bench tests comparing physical characteristics.
Yes
The device is indicated for "delivery of medication for regional anesthesia and pain management," which are therapeutic applications.
No
The device is indicated for the "delivery of medication for regional anesthesia and pain management" and its components are related to catheters and cannulas, which are used for medication delivery, not for diagnosing conditions.
No
The device description explicitly lists physical components such as cannulas, catheters, filters, and caps, indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of medication for regional anesthesia and pain management." This is a therapeutic use, not a diagnostic one.
- Device Description: The components listed (cannula, catheter, filter, etc.) are all consistent with devices used for delivering substances into the body, not for analyzing samples taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver medication, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Over-the-needle (OTN) Catheter System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The Over-the-needle (OTN) Catheter System is contraindicated for the epidural space.
Product codes (comma separated list FDA assigned to the subject device)
BSO, CAZ
Device Description
The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula. E-Cath catheter, filter, FixoLong or FixoCath, locking cap and optional ultrasound cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult 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)
Bench testing was conducted to verify substantial equivalence:
- Needle: stability test bending rigidity:
- Study type: Bench test
- Key results: The bending rigidity of the predicate device's needles and the subject device's needles is less than 0,46mm, meeting the acceptance criterion of ≤0,48mm. Conclusion: Substantially Equivalent.
- Needle: stability test bonding to hub:
- Study type: Bench test
- Key results: For the needles of the subject device and the needles of the predicate device a force significantly higher than the target value of ≥44N has to be applied. Conclusion: Substantially Equivalent.
- Needle: Penetration force:
- Study type: Bench test
- Key results: The subject device's needles as well as the predicate device's needles show equivalent penetration/ insertion forces. Conclusion: Substantially Equivalent.
- Catheter: Leak Tightness:
- Study type: Bench test
- Key results: The catheters of the subject device as well as the catheter of the predicate device meet the acceptance criterion. Conclusion: Substantially Equivalent.
- Catheter: tensile strength:
- Study type: Bench test
- Key results: The catheters of the subject device as well as the catheter of the predicate device meet the acceptance criterion. Conclusion: Substantially Equivalent.
- Catheter: Flow Rate:
- Study type: Bench test
- Key results: The catheters of the subject device as well as the catheter of the predicate device meet the acceptance and have proven to have equivalent flow rates. Conclusion: Substantially Equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K111374, K033018, K013041, K082164
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Pajunk Gmbh Medizintechnologie Christian Quass Director, Regulatory Affairs Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany
Re: K152952
Trade/Device Name: Over-the-Needle (OTN) Catheter System E-Cath Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO. CAZ Dated: June 10, 2016 Received: June 13, 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.
1
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 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,
Michael J. Ryan -S
for Erin I. Keith, M.S. 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) K152952
Device Name
Over-the-Needle (OTN) Catheter System E-Cath
Indications for Use (Describe)
The Over-the-needle (OTN) Catheter System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The Over-the-needle (OTN) Catheter System is contraindicated for the epidural space.
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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Image /page/3/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 circle with an "R" inside is located to the upper right of the "K", indicating that the word is a registered trademark.
Pioneering medical technology
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2016-07-13
Document Control Number: K152952
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 (678) 514-3388 Fax: E-Mail: marco.wohnig@pajunk-usa.com
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Pioneering medical technology
| Device Information: | |
|---|---|
| Device Name: | Over-the-needle (OTN) Catheter System "E-Cath |
| Components: | SonoPlex cannula |
| E-Cath catheter | |
| Locking cap | |
| Injection tube | |
| permanent cannula/ indwelling catheter | |
| Bacterial filter | |
| Optional FixoLong or FixoCath | |
| Sterilization method: | |
| Contract Sterilizer: | Sterigenics Germany GmbH |
| Kasteler straße 45 | |
| 65203 Wiesbaden | |
| Germany, Hessen | |
| Establishment Registration Number: | |
| 3002807090 | |
| Document Control Number | K152952 |
| Classification Name: | Anesthesia Conduction Catheter |
| Classification Reference: | 21 CFR §868.5120 |
| Product Code: | BSO |
| Subsequent Product Code | CAZ |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
| Predicate Device: | K143164 |
| Halyard - Irvine: On-Q QuikBloc Over-the-Needle | |
| (OTN) Catheter Set | |
| SonoPlex cannula (K111374) | |
| E-Cath catheter (K033018, K013041) | |
| Components of the device system already | |
| cleared by sponsor's 510(k)s or exempt or | |
| class I: | Locking cap (K082164) |
| Injection tube (K082164) | |
| Permanent cannula (K033018, K082164) | |
| Bacterial filter (K082164) | |
| Optional FixoLong or FixoCath (K082164) |
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Image /page/5/Picture/1 description: The image shows the word "PAJUNK" in white letters on a green background. The letters are slightly blurred, giving them a soft, glowing effect. A registered trademark symbol is located to the right of the letter "K".
Pioneering medical technology
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for Over-the-needle (OTN) Catheter System, brand name "E-Cath".
It is considered a Class II medical device as defined in 21 CFR §868.5120, product code BSO.
The intended use as well as the individual components this system consist of have been cleared in several 510(k)s sent in earlier by the sponsor. However, the combinations of components as well as the brand names slightly vary from the subject device. Furthermore the intended use in cleared premarket notifications has been less specific than it is in this premarket submission according to 510(k). In order to make the clearance status of the subject device - E-Cath, formerly also called MultiSet Tsui – more obvious, sponsor decided to compile the data in one individual standalone 510(k) comparing the device to competitor's predicate devices.
The technique – over the needle – is rarely identified in submissions with identical indications for use. Usually it is not mentioned whether the technique of placing a catheter is "over the needle" or "through the needle". This detail in application method does not make any difference in evaluating safety, effectiveness and efficacy of the device itself from the technological point of view.
So substantial equivalence is based on earlier submissions by the sponsor as well as based on bench tests comparing the subject device with competitor's devices.
The Over-the-needle (OTN) Catheter System is intended for use with adult patients.
Indications for use subject device:
The Over-the-needle (OTN) Catheter System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The Over-the-needle (OTN) Catheter System is contraindicated for the epidural space.
Device Description:
The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula. E-Cath catheter, filter, FixoLong or FixoCath, locking cap and optional ultrasound cover.
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Image /page/6/Picture/1 description: The image shows the word "PAJUNK" in white letters on a green background. The letters are slightly blurred, giving them a soft, glowing effect. A small circle with an R inside is located to the right of the K, indicating that the word is a registered trademark.
Predicate Devices:
The predicate device for the Over-the-needle (OTN) Catheter System is:
- K143164 of Halyard Irvine: On-Q QuikBloc Over-the-Needle (OTN) Catheter Set .
Determination methods and results of Substantial Equivalence Determination:
Intended Use
Intended Use Subject Device
The Over-the-needle (OTN) Catheter System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The Over-the-needle (OTN) Catheter System is contraindicated for the epidural space.
Intended Use K143164 (Predicate Device)
The ON-Q* QuikBloc* Over-the Needle Catheter Set is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative. percutaneous, or perineural. The ON-Q* QuikBloc* Over-the-Needle Catheter Set is contraindicated for the epidural space.
Conclusion: Substantially Equivalent
Furthermore the comparing benchmarking tests described below have been conducted in order to verify substantial equivalence.
Needle: stability test bending rigidity
Reason for test: The needle has to demonstrate bending stability and resistance aqainst 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 EN ISO 9626: Stainless steel needle tubing for manufacture of medical devices.
Pass/ Fail criteria: According to the standard the acceptance criterion of bending rigidity for the cannula is ≤0,48mm under an applied force of 15N by a span width of 17,5mm.
Results: The bending rigidity of the predicate device's needles and the subject device's needles is less than 0,46mm.
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 EN ISO 7864: Sterile hypodermic needles for single use
Pass/ Fail criteria: The acceptance criterion for the bond between hub and needle tube (pull-off force) is ≥44N.
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Image /page/7/Picture/1 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and slightly blurred, giving them a soft appearance. A small circle with the letter R inside is located to the right of the letter K, indicating that the word is a registered trademark.
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.
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 equivalent penetration/ insertion forces.
Conclusion: Substantially Equivalent
Catheter: Leak Tightness
Reason for test: The catheter and its connections have to demonstrate stability and tightness in order to resist forces reasonably assumed to be applied to the catheter in situ under the defined intended use
Procedure of test: The test procedure is defined by international European standard DIN EN 1618.
Pass/ Fail criteria: The pass-fail-criteria are not defined by the standard and are defined through internal protocols based on risk assessment and clinical evaluation.
Results: The catheters of the subject device as well as the catheter of the predicate device meet the acceptance criterion.
Conclusion: Substantially Equivalent
Catheter: tensile strength
Reason for test: The catheter has to demonstrate stability and tensile strength in order to resist forces reasonably assumed to be applied to the catheter in situ under the defined intended use.
Procedure of test: The test procedure is defined by international European standard DIN EN 10555-1.
Pass/ Fail criteria: The pass-fail-criteria are not defined by the standard and are defined through internal protocols based on risk assessment and clinical evaluation.
Results: The catheters of the subject device as well as the catheter of the predicate device meet the acceptance criterion.
Conclusion: Substantially Equivalent
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Catheter: Flow Rate
Reason for test: The catheter has to demonstrate a stable flow rate in order to perform properly in situ under the defined intended use.
Procedure of test: The test procedure is defined by international European standard DIN EN 10555-1.
Pass/ Fail criteria: The pass-fail-criteria are not defined by the standard and are defined through internal protocols based on risk assessment and clinical evaluation.
Results: The catheters of the subject device as well as the catheter of the predicate device meet the acceptance and have proven to have equivalent flow rates.
Conclusion: Substantially Equivalent
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 | 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, 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: 25ppm = 25μg/(g/device) of Ehyleneoxide (EO); 25ppm = 25μg/(g/device) Ethylene chlorhydrine
Limit for Pyroburden/ endotoxine: 0,06 EU/ml and 2,15 EU/ device acc. to FDA GUIDELINE ON VALIDATION OF LIMULUS AMEBOCYTE LYSATE TEST AS AN END-PRODUCT ENDOTOXIN TEST FOR HUMAN AND ANIMAL PARENTERAL DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL DEVICES - Issued 12/ 1987
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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 custom design. A small, superscript registered trademark symbol is located to the right of the letter "K".
Shelf Life
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 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.
Biocompatibility:
All products comply with ISO 10993-1, 2nd and 3rd edition.
The components the system is assembled from have proven biocompatibility in former 510(k) files also containing the individual components.
The tests listed below have been conducted and accomplished successfully by components and worst case devices:
- In vitro Cytotoxicity ISO 10993-5
- Irritation ISO 10993-10
- In vitro Haemolysis Test on static conditions_ISO 10993-04
- Acute Systemic Toxicity ISO 10993-11
- Test for delayed type hypersensitivity:ISO10993-10 ●
- . Reverse Mutation Assay ISO 10993-03
- . Implantation_ISO 10993-06
- . Implantation Histopatology ISO 10993-06
Therefore and based upon sterilization validation and residuals validation the kits also are considered to be biocompatible.
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Technology Characteristics:
Besides bench testing recognized standards are applicable for the subject device. Compliance is claimed for the standards listed below:
EN ISO 9626: Stainless steel needle tubing for manufacture of medical devices.
The cannula tubing of the cannula included in the subject device fulfills the requirements according to EN ISO 9626. Technological characteristics like material, surface finish, cleanliness, limits for acidity and alkalinity and size designation are complied with.
Regarding the requirement of bending rigidity and breaking resistance the cannula tubes are tested according to the standard (Annex C and D).
According to the standard the acceptance criterion of the bending rigidity for the cannula is ≤ 0,48mm. The applied force was 15N by a span width of 17,5mm. The bending rigidity of the tested cannulas is less than 0,46mm. Therefore the cannula meets this acceptance criterion.
The acceptance criterion of the breaking resistance is: not to break.
During the test the cannula is bended an angle, which is defined in the standard based on to the cannula size, for 20 periods. Means the cannula is bended in two directions. The tested cannulas did not break during the test. Therefore the cannula meets this acceptance criterion.
The cannulas fulfill all the requirements of EN ISO 9626.
EN ISO 7864: Sterile hypodermic needles for single use
The cannulas used comply with the requirements according to EN ISO 7864. Technology characteristics like Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, size designation, needle hub, sheath, tolerances, patency of lumen, freedom from defects, lubricant, needle point, packaging and labeling are in compliance.
Regarding the requirement of bond between hub and needle tube the cannula is tested according to the standard.
The acceptance criterion for the bond between hub and needle tube (pull-off force) is ≥44N.
Therefore the cannula meets the acceptance criterion.
The cannulas fulfill all the requirements of EN ISO 7864.
EN 13097: Hypodermic needles
The penetration force of the cannula is tested according to the standard (Annex D). The standard does not include acceptance criteria but is meant to provide an objective test method.
Compared to the predicate device PAJUNK's cannula is substantially equivalent.
DIN EN 10555-1: Intravascular catheters - sterile and single use catheters - Part 1: General requirements
The catheter fulfills the requirements of the standard DIN EN 10555-1. Technology characteristics like X-ray visibility, biocompatibility, surface, hub, lateral openings, catheter tip, size designation, packaging and labelling are met.
Tensile force, tightness and flow rate are tested according to the standard.
The standard does not give an acceptance criterion for the tensile force.
Due to this. PAJUNK® set the acceptance criterion for this to an internally defined acceptable value to be met without tear off. The catheters of the E-Cath System meet the acceptance criterion.
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For the test on leak tightness, the catheter system has to be tight for a defined period of time as well as a defined pressure. Both systems are tight during the test.
Also for the flow rate no acceptance criterion is given The specification of PAJUNK® catheters regarding the flow rate is internally defined by the sponsor based on risk manaqement and clinical evaluation. The flow rate of the tested E-Cath catheter meets the acceptance criterion.
The requirement of corrosion resistance does not apply due to no metal components of the catheter.
The requirement of high-performance injection does not apply because the catheter is not intended for high-performance injection.
The catheters fulfill all the requirements.
DIN EN 1618: Catheters other than intravascular catheters - Test methods for common properties
The catheter of the E-Cath System fulfills the requirements of the standard DIN EN 1618. Requirements like tensile properties, tightness, flow rate as well as the safety of connectors are tested according to the standard.
The standard does not give an acceptance criterion for the tensile force.
Due to this, PAJUNK® set the acceptance criterion for this to an internally defined mustvalue without tear off.
The catheters of the E-Cath System meet the acceptance criterion.
For the test on tightness, the catheter system has to be tight for a defined period of time as well as a defined pressure. Both systems are tight during the test.
Also for the flow rate no acceptance criterion is given.
The specification of PAJUNK® catheters regarding the flow rate is defined as internal must-value. The flow rate of the tested E-Cath catheter meets the acceptance criterion.
The requirement of corrosion resistance does not apply due to no metal components of the catheter
The catheters and needles fulfill all the requirements for the essential technological characteristics.
As proven in the predicate device discussion's bench testing as well as in the bench testing and standard compliance testing of the subject device the Over-the-needle (OTN) Catheter System E-Cath and its predicate device have the same basic fundamental technological characteristics.
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, bench testing and bench marking demonstrates that the subject devices are substantially equivalent to the predicate devices and substantially equivalent in technical description to devices already cleared for market and therefore demonstrated to be as safe and effective as the legal predicate devices.