Spinal Manometer NRFit; Spinal Manometer LUER

K170305 · PAJUNK GmbH Medizintechnologie · FMJ · Jul 25, 2017 · General Hospital

Device Facts

• Record ID: K170305
• Device Name: Spinal Manometer NRFit; Spinal Manometer LUER
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: FMJ · General Hospital
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2500
• Device Class: Class 2

Intended Use

The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

Device Story

The Spinal Manometer is a sterile, disposable device used to measure CSF pressure during lumbar punctures. It consists of a manometer scale and a three-way stopcock (either NRFit or LUER connector). The device is operated by a clinician during the procedure. The clinician connects the manometer to the spinal needle assembly; the CSF pressure is read directly from the scale in cmHg increments. The device facilitates accurate pressure monitoring, which aids in clinical decision-making during spinal procedures. It is supplied sterile for single use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including sterilization validation (ISO 11135), biocompatibility (ISO 10993-1), and mechanical performance testing (leakage, stress cracking, axial load, and torque) per ISO 80369-6 and ISO 80369-7 standards.

Technological Characteristics

Materials: PVC, Polycarbonate, HDPE. Connectivity: NRFit (ISO 80369-6) or LUER (ISO 80369-7). Form factor: Disposable manometer with integrated three-way stopcock. Sterilization: Ethylene Oxide (ISO 11135). No direct or indirect patient contact.

Indications for Use

Indicated for measuring Cerebrospinal Fluid (CSF) pressure during lumbar puncture procedures.

Regulatory Classification

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.

Predicate Devices

• BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (K032432)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone] Establishment Registration Number: 9611612

#### USA Contact:

PAJUNK MEDICAL SYSTEMS 6611 Bay Circle, Suite 140 Norcross, GA 30071 Phone +1 (888) 9PAJUNK (72-5865) Fax [phone]

Establishment Registration Number: 3004076349

#### Contact

Marco Wohniq President PAJUNK® Medical Systems L.P. Phone: [phone] Direct: [phone] Cell: [phone] Fax: [phone] E-Mail: [e-mail]

#### Contact:

Christian G. H. Quass Director Requlatory Affairs, Safety Officer Patricia Weisbrod Regulatory Affairs Manager Fon: [phone] Fax: [phone] E-Mail: [e-mail] E-Mail: [e-mail]

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### PA-JUN

Pioneering medical technology

| Device Information: | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Spinal Manometer NRFit<br>Spinal Manometer LUER |
| Sterilization method: | Ethylene Oxide<br>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<br>Kasteler straße 45<br>65203 Wiesbaden<br>Germany, Hessen<br>Establishment Registration Number:<br>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<br>BUSSE HOSPITAL DISPOSABLES SPINAL<br>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.

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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<br>s | Predicate device 1<br>Spinal manometer<br>K032432 Busse Hospital<br>Disposables | Subject Device<br>Spinal manometer<br>Pajunk® GmbH<br>Medizintechnologie | Result of comparison,<br>if necessary with<br>rationale |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The spinal manometer does neither have direct nor indirect patient<br>contact. Therefore and based upon ISO10993-1 biocompatibility testing<br>is obsolete. | The spinal manometer does neither have direct nor indirect patient<br>contact. Therefore and based upon ISO10993-1 biocompatibility testing<br>is obsolete. | Substantially equivalent |
| Packaging | The Spinal Manometer is placed<br>in a rigid tray composed of high<br>impact plastic (polystyrene). The<br>tray is wrapped and packaged in a<br>soft pouch with Tyvek lid. The<br>pouch is heat sealed. | Individually packed and sterilized<br>or as set component.<br>Single sterile in Tyvek bag (heat<br>sealed)<br>As a set component packed in a<br>rigid tray, wrapped and packaged<br>in a soft blister pack (heat sealed). | Same set packaging<br>The PAJUNK®<br>individual packaging<br>was selected according<br>to a validated<br>sterilization and<br>transportation process |
| Overall design:<br>spinal<br>Manometer | Materials: Polyethylene,<br>Polycarbonate<br>No patient contact | Materials: PVC, Polycarbonate,<br>HDPE<br>No patient contact | Both spinal<br>manometers do not<br>have direct patient<br>contact and are made<br>from plastic materials |
| Scale<br>(manometer) | Image: Spinal manometer scale 0.2 cm | Image: Spinal manometer scale 1 cm | Both systems allow<br>easy reading of spinal<br>pressure in cmHg<br>increments |

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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<br>s | Predicate device 1<br>Spinal manometer<br>K032432 Busse Hospital<br>Disposables | Subject Device<br>Spinal manometer<br>Pajunk® GmbH<br>Medizintechnologie | Result of comparison,<br>if necessary with<br>rationale |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Three-way-<br>stopcock | Image: Predicate device 1 three-way stopcock<br>Detachable/ slip on three -way-<br>stopcock LUER<br>Distal connector: male<br>Proximal connector: female | Image: Subject device three-way stopcock<br>Three-way-stopcock, not<br>detachable (glued), LUER or<br>NRFit<br>Distal connector: male<br>Proximal connector: female | Both systems use 3-<br>way stopcocks |
| Capacity | Length: 36cm, extension up to<br>55cm possible | Length: 34cm, extension for 20cm<br>(54cm in total) or rather 40cm<br>(74cm in total) possible | Both systems can be<br>extended |
| Connectivity | ISO 594-1 and ISO 594-2 (Luer<br>connectivity) | 80369-7 (Luer connectivity) ISO<br>80369-6, -20 NRFit (connectors<br>for neuroaxial applications) | All 3-way stopcock have<br>standardized<br>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

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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 | evacuation<br>2 airwashes |
| Aeration period | residual EtO-gas is removed in circulating<br>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.

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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<br>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.