(231 days)
No
The device description and performance studies focus on the physical connectivity, leak tightness, and material properties of a catheter adapter, with no mention of AI or ML capabilities.
No.
The device is a connection adapter for existing catheters and fluid administration devices, not a device that itself delivers therapy.
No
The device is a connection adapter for administering anesthetic agents, not for diagnosing conditions.
No
The device description clearly states it is a "connection device" and a "sterile finished disposable device," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "delivery of anesthetics" and "continuous administration of anesthetic agents" through a catheter. This is a therapeutic/delivery function, not a diagnostic one.
- Device Description: The description focuses on connecting anesthetic and fluid administration devices to a catheter. It describes a physical connection for delivering substances into the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
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 entirely focused on delivering substances into the body.
N/A
Intended Use / Indications for Use
The Catheter Clamping Adapter, a connection device, is used to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics.
The connector is used in conjunction with catheters for continuous administration of anesthetic agents.
Product codes (comma separated list FDA assigned to the subject device)
BSO
Device Description
The Catheter Clamping Adapter NRFit (ISO80369-6) and Catheter Clamping Adapter LUER (ISO80369-7) is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. It is intended to provide a specified connection (either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7) to an unspecified proximal end of a 20G anesthesia conduction catheter (epidural or peripheral). The device body is made of Polycarbonate and the clamping seal is Silicone.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technology Characteristics/ Performance Testing
Subject Device:
Connectivity: LUER and NRFit™ (ISO 80369-6 and ISO 80369-7).
Leak Tightness: Complies with internal protocol
Security of connection, tensile strength: Complies with internal protocol
Predicate Devices:
Leak Tightness: Complies with internal protocol of the sponsor
Security of connection, tensile strength: Complies with internal protocol of the sponsor
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 10-6 as well as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and Et0-residuals as well as shelf life have been validated.
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. Biocompatibility is evaluated based on ISO10993-1, sterilization, and residuals validation.
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:
- Sterilization: ISO 11135 (Pass)
- Residuals: ISO 10993-7 (Pass)
- Biocompatibility: ISO 10993-1 (Pass)
- Liquid Leakage: ISO 80369-7, 6.1 (Pass); ISO 80369-6, 6.1 (Pass)
- Air Leakage: ISO 80369-7, 6.2 (Pass); ISO 80369-6, 6.2 (Pass)
- Stress Cracking: ISO 80369-7, 6.3 (Pass); ISO 80369-6, 6.3 (Pass)
- Axial Load: ISO 80369-7, 6.4 (Pass); ISO 80369-6, 6.4 (Pass)
- Unscrewing torque: ISO 80369-7, 6.5 (Pass); ISO 80369-6, 6.5 (Pass)
- Overriding: ISO 80369-7, 6.6 (Pass); ISO 80369-6, 6.6 (Pass)
- Leak Tightness: Internal Protocol (Pass)
- Security of connection: Internal Protocol (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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include compliance with various ISO standards for leakage, tensile force, and sterilization.
- Tensile Force: > 8N (identical to predicate)
- SAL (Sterility Assurance Level): 10-6
- Shelf Life: 5 years (no decrease in performance after 5 years)
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.
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).
0
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May 3, 2018
PAJUNK GmbH Medizintechnologie Christian Quass Director of Regulatory Affairs, Safety Officer Karl-Hall-Str. 1 Geisingen, 78187 Germany
Re: K172777
Trade/Device Name: Catheter Clamping Adapter NRFit (ISO80369-6) and Catheter Clamping Adapter LUER (ISO80369-7) Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: April 4, 2018 Received: April 6, 2018
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 of medical device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
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) K172777
Device Name
Catheter Clamping Adapter NRFit (ISO80369-6) and Catheter Clamping Adapter LUER (ISO80369-7)
Indications for Use (Describe)
The Catheter Clamping Adapter, a connection device, is used to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics.
The connector is used in conjunction with catheters for continuous administration of anesthetic agents.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
PAJUNK
Pioneering medical technology
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2018-04-25
Document Control Number: K172777
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 Requlatory 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 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
4
Device Name and Classification Details
| Device Information: | |
|---|---|
| Device Name: | Catheter Clamping Adapter NRFit™ (ISO80369-6) |
| Catheter Clamping Adapter LUER (ISO80369-7) | |
| Sterilization method: | Ethylene Oxide |
| disposable device, supplied sterile to the end user and | |
| non-sterile intended to be sterilized prior to use to | |
| repackagers/ medical device manufacturers | |
| Contract Sterilizer: | Sterigenics Germany GmbH |
| Kasteler straße 45 | |
| 65203 Wiesbaden | |
| Germany, Hessen | |
| Establishment Registration Number: 3002807090 | |
| Document Control Number | K172777 |
| Trade Name: | Clamping Adapter |
| Common name | Catheter Connector |
| Classification Name: | Anaesthesia Conduction Catheter |
| Classification Reference: | 21 CFR 868.5120 |
| Product Code: | BSO |
| Regulatory Class: | II |
| Panel: | Anesthesiology |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the Catheter Clamping Adapter with either NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7.
The device is intended to provide a specified connection (either NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7) to an unspecified proximal end of a 20G anesthesia conduction catheter (epidural or peripheral). Therefore it may also be considered an accessory for epidural and peripheral anesthesia conduction catheters.
The Catheter Clamping Adapter is considered a Class II medical device according to the predicate device as defined in 21 CFR §868.5120, product code BSO.
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.
5
Image /page/5/Picture/0 description: The image features the word "PAJUNK" in bold, white letters against a teal background. The font is sans-serif and appears to be slightly blurred, giving it a soft, glowing effect. A registered trademark symbol is located to the right of the letter "K".
Indications for use
The Catheter Clamping Adapter, a connection device, is used to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics.
The connector is used in conjunction with catheters for continuous administration of anesthetic agents.
Determination methods and results of Substantial Equivalence Determination:
Intended Use Design Performance
Result: Substantially Equivalent
Result: Substantially Equivalent
Result: Substantially Equivalent
Equivalence in materials used
| Characteristics | Predicate device
K022019
BBraun Perifix Catheter
Connector | Subject Device
Catheter Clamping Adapter | Result of comparison,
if necessary with
rationale |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Both devices are classified as externally communicating. Therefore and
based upon ISO10993-1 biocompatibility applies. | | Substantially equivalent |
| Packaging | Individually sterile in soft blister
pouch or as part of a kit | Individually sterile in soft blister
pouch or as part of a kit | Same packaging
The PAJUNK®
individual packaging
was selected according
to a validated
sterilization and
transportation process |
| Indications for
Use | A connection device used to provide
various anesthetic and fluid
administration devices with a single,
common access point to an 18 or 20
gauge Perifix catheter for delivery of
anesthetics. The connector is used in
conjunction with 18 or 20 gauge Perifix
catheters for continuous administration
of anesthetic agents. | The Catheter Clamping Adapter, a
connection device, is used to provide
various anesthetic and fluid
administration devices with a single,
common access point to a catheter for
delivery of anesthetics.
The connector is used in conjunction
with catheters for continuous
administration of anesthetic agents. | Substantially equivalent
Size limitation in
predicate device has
been altered by
K032144 and K033952
of predicate's sponsor |
| Overall design: | Adapter clamps catheter | Adapter clamps catheter | Substantially equivalent |
6
PAJUNK®
K172777
| Pioneering medical technology | ||
|---|---|---|
| Characteristics | Predicate device
K022019
BBraun Perifix Catheter
Connector | Subject Device
Catheter Clamping Adapter | Result of comparison, if necessary with rationale |
|-----------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture | Image: BBraun Perifix Catheter Connector | Image: Catheter Clamping Adapter | Both systems allow
easy handling and
connecting with one
hand |
| Materials used | Plastics, rubber | Body Polycarbonate
Clamping seal Silicone | Similar
Each of the materials
used either in the
Predicate Devices or
the Subject Device are
established materials
used for manufacturing
medical devices. |
| Connectivity | ISO 80369-7 | ISO 80369-6 NRFitTM
ISO 80369-7 LUER | Both systems do have
identical connectivity
towards syringe and
needle; 2017's state of
the art connection type
is NRFitTM which slightly
differs in dimensions of
the male and female
connectors in order to
avoid misconnections. |
| Tightness | Leak tight under normal conditions
when used according to
instructions for use | Leak tight under normal
conditions when used according
to instructions for use | identical |
| Tensile Force | > 8N | > 8N | identical |
7
Image /page/7/Picture/0 description: The image features the word "PAJUNK" in a bold, sans-serif font. The letters are white with a subtle gradient effect, giving them a slightly three-dimensional appearance. The background is a solid teal color, providing a strong contrast that makes the text stand out. A small registered trademark symbol is visible to the right of the letter "K".
Equivalence in the Indications for use
Subiect Device:
The Catheter Clamping Adapter, a connection device, is used to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics.
The connector is used in conjunction with catheters for continuous administration of anesthetic agents.
Predicate Devices:
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 gauge Perifix catheters for continuous administration of anesthetic agents.
Discussion
The intended use of the predicate devices and of the subject device are identical. The indications for use differ slightly but the differences do not raise different questions of safety or effectiveness.
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
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Image /page/8/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence is "K172777". The characters are in a bold, sans-serif font and are black against a white background.
Technology Characteristics/ Performance Testing
Subject Device:
Connectivity: LUER and NRFit™ (ISO 80369-6 and ISO 80369-7).
Leak Tightness: Complies with internal protocol
Security of connection, tensile strength: Complies with internal protocol
Predicate Devices:
Leak Tightness: Complies with internal protocol of the sponsor
Security of connection, tensile strength: Complies with internal protocol of the sponsor
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 10-6 as well as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and Et0-residuals as well as shelf life have been validated.
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.
9
Image /page/9/Picture/1 description: The image shows the alphanumeric string "K172777" in a bold, sans-serif font. The string is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, creating a clear and legible sequence.
The clamping adapters are also available in bulk non sterile. If appropriately packed and sterilized with Ethylene oxide according to the parameters above the technological parameters remain unchanged. However, final responsibility for sterilization remains with the customer of catheter clamping adapters purchased bulk non-sterile.
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.
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 |
10
PAJUNK®
K172777
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 |
| Leak Tightness | Internal Protocol | n.a. | Pass |
| Security of connection | 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 devices and the subject device of this submission as well as the validated sterilization process and the results of the standard testing and performance testing demonstrates that the subject device is substantially equivalent to the predicate device.