(175 days)
Not Found
No
The device description and performance studies focus on physical properties and standard compliance, with no mention of AI/ML or data processing.
No
The device is intended to measure the pressure of Cerebrospinal Fluid (CSF), which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a disease or condition.
Yes
The device measures the pressure of Cerebrospinal Fluid (CSF), which is a key parameter used by medical professionals to diagnose various neurological conditions.
No
The device description explicitly states it is a "sterile finished disposable device" made of physical materials (PVC, Polycarbonate, HDPE) and includes testing for physical properties like leakage, stress cracking, and axial load, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure." This is a direct measurement of a physical parameter (pressure) within the body, not an analysis of a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the physical components and connectors used for the measurement. It doesn't mention any reagents, assays, or analytical processes typically associated with IVDs.
- No mention of sample analysis: The document does not describe any process of analyzing a biological sample (like CSF) for chemical, biological, or immunological properties.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device measures a physical property (pressure) directly during a procedure, which falls outside the scope of IVD definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMJ
Device Description
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.
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.
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)
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:
- Sterilization (ISO 11135):Pass
- Residuals (ISO 10993-7): Pass
- Biocompatibility (ISO 10993-1): Pass
- 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
- 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
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.
Not Found
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
§ 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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
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
1
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
2
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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3
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
4
PA-JUN
Pioneering medical technology
| Device Information: | |
|---|---|
| Device Name: | Spinal Manometer NRFit |
| Spinal Manometer LUER | |
| 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 | 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 | K032432 |
| BUSSE HOSPITAL DISPOSABLES SPINAL | |
| MANOMETER |
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.
5
Image /page/5/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and sans-serif. A small registered trademark symbol is located to the right of the letter "K".
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
| Characteristic
s | Predicate device 1
Spinal manometer
K032432 Busse Hospital
Disposables | Subject Device
Spinal manometer
Pajunk® GmbH
Medizintechnologie | Result of comparison,
if necessary with
rationale |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The spinal manometer does neither have direct nor indirect patient
contact. Therefore and based upon ISO10993-1 biocompatibility testing
is obsolete. | The spinal manometer does neither have direct nor indirect patient
contact. Therefore and based upon ISO10993-1 biocompatibility testing
is obsolete. | Substantially equivalent |
| Packaging | The Spinal Manometer is placed
in a rigid tray composed of high
impact plastic (polystyrene). The
tray is wrapped and packaged in a
soft pouch with Tyvek lid. The
pouch is heat sealed. | Individually packed and sterilized
or as set component.
Single sterile in Tyvek bag (heat
sealed)
As a set component packed in a
rigid tray, wrapped and packaged
in a soft blister pack (heat sealed). | Same set packaging
The PAJUNK®
individual packaging
was selected according
to a validated
sterilization and
transportation process |
| Overall design:
spinal
Manometer | Materials: Polyethylene,
Polycarbonate
No patient contact | Materials: PVC, Polycarbonate,
HDPE
No patient contact | Both spinal
manometers do not
have direct patient
contact and are made
from plastic materials |
| Scale
(manometer) | Image: Spinal manometer scale 0.2 cm | Image: Spinal manometer scale 1 cm | Both systems allow
easy reading of spinal
pressure in cmHg
increments |
6
Image /page/6/Picture/0 description: The image shows the text 'K170305' in a bold, sans-serif font. The text is black against a white background. The letters and numbers are evenly spaced and clearly legible.
Image /page/6/Picture/1 description: The image shows the word "PAJUNK" in white letters against a teal background. The letters are bold and sans-serif. A small registered trademark symbol is located to the right of the letter "K".
Pioneering medical technology
| Characteristic
s | Predicate device 1
Spinal manometer
K032432 Busse Hospital
Disposables | Subject Device
Spinal manometer
Pajunk® GmbH
Medizintechnologie | Result of comparison,
if necessary with
rationale |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Three-way-
stopcock | Image: Predicate device 1 three-way stopcock
Detachable/ slip on three -way-
stopcock LUER
Distal connector: male
Proximal connector: female | Image: Subject device three-way stopcock
Three-way-stopcock, not
detachable (glued), LUER or
NRFit
Distal connector: male
Proximal connector: female | Both systems use 3-
way stopcocks |
| Capacity | Length: 36cm, extension up to
55cm possible | Length: 34cm, extension for 20cm
(54cm in total) or rather 40cm
(74cm in total) possible | Both systems can be
extended |
| Connectivity | ISO 594-1 and ISO 594-2 (Luer
connectivity) | 80369-7 (Luer connectivity) ISO
80369-6, -20 NRFit (connectors
for neuroaxial applications) | All 3-way stopcock have
standardized
connectivities |
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
7
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 (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.
8
Image /page/8/Picture/0 description: The image shows the word "PAJUNK" in white font on a green background. The font is sans-serif and appears to be bolded. There is a registered trademark symbol to the right of the letter K.
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 Glue | |||
| Connection | 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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Image /page/9/Picture/0 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 registered trademark symbol is visible to the right of the letter "K".
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.