(175 days)
The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.
The Spinal Lumbar Puncture Manometer with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. The manometer is considered a Class II medical device as defined in 21 CFR §880.2500, product code FMJ. 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 repackagers/ medical device manufacturers. Materials: PVC, Polycarbonate, HDPE. No patient contact.
Here's a breakdown of the acceptance criteria and the study information for the Spinal Manometer NRFit and Spinal Manometer LUER, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized standards and internal protocols, with the reported performance being "Pass" for all tests.
| Acceptance Criteria / Test Detail | Standard / Protocol | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135 | Pass |
| Residuals | ISO 10993-7 | Pass |
| Biocompatibility | ISO 10993-1 | Pass (based on no patient contact & sterilization/residuals validation) |
| Liquid Leakage (Luer) | ISO 80369-7, 6.1 | Pass |
| Air Leakage (Luer) | ISO 80369-7, 6.2 | Pass |
| Stress Cracking (Luer) | ISO 80369-7, 6.3 | Pass |
| Axial Load (Luer) | ISO 80369-7, 6.4 | Pass |
| Unscrewing torque (Luer) | ISO 80369-7, 6.5 | Pass |
| Overriding (Luer) | ISO 80369-7, 6.6 | Pass |
| Liquid Leakage (NRFit) | ISO 80369-6, 6.1 | Pass |
| Air Leakage (NRFit) | ISO 80369-6, 6.2 | Pass |
| Stress Cracking (NRFit) | ISO 80369-6, 6.3 | Pass |
| Axial Load (NRFit) | ISO 80369-6, 6.4 | Pass |
| Unscrewing torque (NRFit) | ISO 80369-6, 6.5 | Pass |
| Overriding (NRFit) | ISO 80369-6, 6.6 | Pass |
| Accuracy of Markings | Internal protocol | Pass |
| Durability of Markings | Internal Protocol | Pass |
| Stability of Glue Connection | Internal Protocol | Pass |
| Compatibility LUER | Internal Protocol | Pass |
| Compatibility NRFit | Internal Protocol | Pass |
| Batch Inspection report | Internal Protocol | Pass |
| Sterility Assurance Level (SAL) | 10^-6 | Met |
| Ethylene Oxide (EtO) Residuals | 25 ppm | Met |
| Ethylene Chlorhydrine (ECH) Residuals | 25 ppm | Met |
| Pyroburden/Endotoxin | 0.06 EU/ml and 2.15 EU/device | Met |
| Shelf Life Performance | 5 years | No decrease in performance after real-time and accelerated aging |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of devices or test samples used for each individual performance test (e.g., liquid leakage, axial load). It mentions:
- Sterility tests: "performed using worst case devices already cleared for market and being packed in identical packaging (material and dimensions)."
- Shelf-life performance: "tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years)."
The provenance of the data is internal testing conducted by PAJUNK® GmbH Medizintechnologie, located in Geisingen, Germany, and its contract sterilizer, Sterigenics Germany GmbH, located in Wiesbaden, Germany. All testing appears to be retrospective in the sense that it's performed on manufactured devices to demonstrate compliance, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are primarily engineering and laboratory-based performance tests against established international standards (ISO) and internal protocols. There is no mention of human expert evaluation to establish a "ground truth" in the clinical sense, as the device is for mechanical measurement and connectivity rather than diagnostic interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the tests are objective, quantifiable physical and chemical performance metrics against defined standards, not subjective assessments requiring expert adjudication. The result for each test is a simple "Pass" or "Fail."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation of clinical data (e.g., AI in radiology). The Spinal Manometer is a physical device for measuring pressure, not an AI or diagnostic imaging tool.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is not relevant. The device operates independently of human interpretation of its internal function; humans use it to observe a reading. All performance tests evaluated the device in its intended operational context without human interpretation being part of its core "performance" beyond reading the scale.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on:
- International Standards: Adherence to ISO standards (e.g., ISO 11135, ISO 10993-7, ISO 80369-6, ISO 80369-7) defines acceptable physical and chemical properties.
- Internal Protocols: For aspects not covered by specific ISO standards (e.g., Accuracy/Durability of Markings, Glue Connection Stability), internal, presumably validated, protocols establish the acceptance criteria.
- Measurement against predefined limits: For sterilization residuals and endotoxin, specific quantitative limits (e.g., 25 ppm, 0.06 EU/ml) serve as the ground truth.
8. The Sample Size for the Training Set
There is no training set as this device is not an AI/machine learning product. The term "training set" doesn't apply.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
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Public Health Service
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July 25, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
PAJUNK GmbH Medizintechnologie Christian Quass Director Regulatory Affairs, Safety Officer Karl-Hall-Str. 1 78187 Geisingen, Germany
Re: K170305
Trade/Device Name: Spinal Manometer NRFit; Spinal Manometer LUER Regulation Number: 21 CFR 880.2500 Regulation Name: Spinal Fluid Manometer Regulatory Class: Class II Product Code: FMJ Dated: June 9, 2017 Received: June 15, 2017
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
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Mark S. Fellman -S
for
Lori A. Wiggins, MTP, CLT 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) K170305
Device Name Spinal Manometer NRFit Spinal Manometer LUER
Indications for Use (Describe)
The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.
| 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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PAJUNK
Pioneering medical technology
510(k) Summary as required by 21 CFR 807.92(c).
Date of Preparation: 2017-07-20
Document Control Number: K170305
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
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
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
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PA-JUN
Pioneering medical technology
| Device Information: | |
|---|---|
| Device Name: | Spinal Manometer NRFitSpinal Manometer LUER |
| Sterilization method: | Ethylene Oxidedisposable 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 GmbHKasteler straße 4565203 WiesbadenGermany, HessenEstablishment Registration Number:3002807090 |
| Document Control Number | K170305 |
| Classification Name: | manometer, spinal-fluid |
| Classification Reference: | 21 CFR 880.2500 |
| Product Code: | FMJ |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | General Hospital |
| Predicate Device by competitor | K032432BUSSE HOSPITAL DISPOSABLES SPINALMANOMETER |
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the Spinal Lumbar Puncture Manometer with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7.
The manometer is considered a Class II medical device as defined in 21 CFR §880.2500, product code FMJ.
Substantial equivalence is based on a competitor's device.
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 repackagers/ medical device manufacturers.
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Pioneering medical technology
Indications for use
The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.
Determination methods and results of Substantial Equivalence Determination:
| Intended Use | Result: Substantially Equivalent |
|---|---|
| Comparison of outer appearance and assemblies | Result: Substantially Equivalent |
| Leak Tightness test | Result: Substantially Equivalent |
| Stability of connections, mechanical test | Result: Substantially Equivalent |
| Stability of needle/ manometer bridge | Result: Substantially Equivalent |
Equivalence in materials used
| Characteristics | Predicate device 1Spinal manometerK032432 Busse HospitalDisposables | Subject DeviceSpinal manometerPajunk® GmbHMedizintechnologie | Result of comparison,if necessary withrationale |
|---|---|---|---|
| Biocompatibility | The spinal manometer does neither have direct nor indirect patientcontact. Therefore and based upon ISO10993-1 biocompatibility testingis obsolete. | The spinal manometer does neither have direct nor indirect patientcontact. Therefore and based upon ISO10993-1 biocompatibility testingis obsolete. | Substantially equivalent |
| Packaging | The Spinal Manometer is placedin a rigid tray composed of highimpact plastic (polystyrene). Thetray is wrapped and packaged in asoft pouch with Tyvek lid. Thepouch is heat sealed. | Individually packed and sterilizedor as set component.Single sterile in Tyvek bag (heatsealed)As a set component packed in arigid tray, wrapped and packagedin a soft blister pack (heat sealed). | Same set packagingThe PAJUNK®individual packagingwas selected accordingto a validatedsterilization andtransportation process |
| Overall design:spinalManometer | Materials: Polyethylene,PolycarbonateNo patient contact | Materials: PVC, Polycarbonate,HDPENo patient contact | Both spinalmanometers do nothave direct patientcontact and are madefrom plastic materials |
| Scale(manometer) | Image: Spinal manometer scale 0.2 cm | Image: Spinal manometer scale 1 cm | Both systems alloweasy reading of spinalpressure in cmHgincrements |
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Pioneering medical technology
| Characteristics | Predicate device 1Spinal manometerK032432 Busse HospitalDisposables | Subject DeviceSpinal manometerPajunk® GmbHMedizintechnologie | Result of comparison,if necessary withrationale |
|---|---|---|---|
| Three-way-stopcock | Image: Predicate device 1 three-way stopcockDetachable/ slip on three -way-stopcock LUERDistal connector: maleProximal connector: female | Image: Subject device three-way stopcockThree-way-stopcock, notdetachable (glued), LUER orNRFitDistal connector: maleProximal connector: female | Both systems use 3-way stopcocks |
| Capacity | Length: 36cm, extension up to55cm possible | Length: 34cm, extension for 20cm(54cm in total) or rather 40cm(74cm in total) possible | Both systems can beextended |
| Connectivity | ISO 594-1 and ISO 594-2 (Luerconnectivity) | 80369-7 (Luer connectivity) ISO80369-6, -20 NRFit (connectorsfor neuroaxial applications) | All 3-way stopcock havestandardizedconnectivities |
Each of the materials used either in the Predicate Devices or the Subject Device are established materials used for manufacturing medical devices.
Equivalence in the Indications for use
Subject Device:
The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.
Predicate Devices:
The device is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during lumbar puncture procedure.
Discussion
The indications for use as well as the intended use of the predicate device and of the subject device are substantially equivalent.
Conclusion: Substantially Equivalent
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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.
The limits listed below are met by each device:
Limits for Residuals: 25ppm = 25μg(g/device) of Ehyleneoxide (ΕΟ); 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
Sterilization of devices purchased bulk by Repackagers/ Relabellers/ Kit Manufacturers:
The spinal manometers 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 spinal manometers purchased bulk non-sterile.
Shelf Life
Efficacy of sterile product´s lifecycle has been validated.
Sterility tests have been performed using worst case devices already cleared for market and being packed in identical packaging (material and dimensions).
Performance of the essential performance of the device (NRFit and LUER connection, stability of connections and markings) has been tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years). There is no decrease in performance after 5 years.
Shelf-life is set to 5 years.
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Biocompatibility:
All products comply with ISO 10993-1, 2nd and 3rd edition.
The spinal manometer does neither have direct nor indirect patient contact. Therefore and based upon ISO10993-1 further biocompatibility testing is obsolete.
Therefore and based upon sterilization and residuals validation the devices are considered to be biocompatible.
Technology Characteristics/ Performance Testing
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 connector 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 |
| 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 |
| Accuracy of Markings | Internal protocol | n.a. | Pass |
| Durability of Markings | Internal Protocol | n.a. | Pass |
| Stability of GlueConnection | Internal Protocol | n.a. | Pass |
| Compatibility LUER | Internal Protocol | n.a. | Pass |
| Compatibility NRFit | Internal Protocol | n.a. | Pass |
| Batch Inspection report | Internal Protocol | n.a. | Pass |
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Pioneering medical technology
Conclusion:
The predicate devices chosen for demonstrating substantial equivalence is the BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER manufactured by BUSSE HOSPITAL DISPOSABLES, INC. p.o. box 2156 huntington, CT 06484 and cleared by the Food and Drug Administration for market under K032432, product code FMJ, review panel General Hospital.
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 demonstrates that the subject device is substantially equivalent to the predicate device already cleared for market and therefore demonstrated to perform as accurate as the legal predicate device.
§ 880.2500 Spinal fluid manometer.
(a)
Identification. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.(b)
Classification. Class II (performance standards).