K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR

K130023 · Np Medical, Inc. · FPA · Apr 3, 2013 · General Hospital

Device Facts

• Record ID: K130023
• Device Name: K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
• Applicant: Np Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The K100 Neutral Displacement Needle Free Connector is a single patient use device for needleless access to the IV line and/or IV catheter during IV therapy. The K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

Device Story

K100 Neutral Displacement Needle Free Connector is a sterile, single-patient-use, swabable, normally closed, luer-activated valve; facilitates needleless access to IV lines/catheters. Device consists of housing, fluid channel, translating member (lower gland), post, and upper seal; internal components lubricated with silicone oil. Operated by clinicians in clinical settings; connects to standard ISO luer interfaces. Functions as a closed system to prevent flow when not activated; allows fluid delivery or aspiration upon luer activation. Neutral displacement design minimizes fluid movement during connection/disconnection, potentially reducing catheter occlusion or reflux. Bench testing confirms performance, including microbial ingress resistance, pressure rating (325 psi), and chemical compatibility (lipids, alcohol, CHG).

Clinical Evidence

Bench testing only. No clinical data. Verification and validation testing included air bolus/bubble-free priming, repeat insertion, blood flushing, bolus back pressure, docking stability, flow rate, fluid displacement, gland height, hydraulic burst leak, ISO 594 compliance, lipid resistance, priming/residual volume, and stress resistance to swabbing chemicals (IPA and CHG). Microbial ingress, sterilization, and shelf-life validation were also performed.

Technological Characteristics

Materials: Polycarbonate (PC) and silicone (latex/DEHP-free). Principle: Normally closed, luer-activated valve with translating member. Dimensions: 0.12 mL priming volume. Connectivity: ISO luer compatible. Sterilization: Validated. Pressure rating: 325 psi. Mechanical design: Swabable, neutral displacement.

Indications for Use

Indicated for single patient use for needleless access to IV lines or catheters during IV therapy, including direct injection, intermittent/continuous infusion, or aspiration.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• NP Medical Capless Needleless Luer Connector (K973916)

Submission Summary (Full Text)

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K 130023

NP Medical Premarket Notification – 510(k) K100 Needle Free Connector SN000 . Page 1 of 5

# APR 0 3 2013

# 510(k) SUMMARY

December 31, 2012

## Applicant:

NP Medical. 101 Union St Clinton, MA 01501 Tel: [phone]

## Contact Person:

Luis J Maseda General Manager

Trade Name: K100 Neutral Displacement Needle Free Connector Common Name: Needleless IV connector Classification Name: Intravascular Administration Set Classification Panel: 80-General Hospital

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NP Medical Premarket Notification - 510(k) K100 Needle Free Connector SN000 Page 2 of 5

#### 1.0 DEVICE SUMMARY

The K100 Neutral Displacement Needle Free Connector (K100) is a medical device designed for direct injection, intermittent infusion, continuous infusion, or aspiration without the need for sharps devices.

### Classification Information

Table 1: Device Classification

| Classification or<br>descriptor | Name or designation |
|---------------------------------|-------------------------------------------------|
| Trade Name | K100 Neutral Displacement Needle Free Connector |
| Common Name | Needleless IV connector |
| Classification<br>Name | Intravascular Administration Set |
| Classification<br>Panel | 80-General Hospital |
| Product Code | FPA |
| Requlation<br>Number | 21 CFR 880.5440 |

#### 2.0 INTENDED USE AND INDICATIONS FOR USE

### Indications for Use

The K100 Neutral Displacement Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

#### 3.0 DEVICE DESCRIPTIONS

The K100 Neutral Displacement Needleless Connector is a sterile, single patient use, swabable, normally closed, luer-activated, valved connector.

The K100 valve is comprised of a:

- a housing (inlet and outlet),
- a fluid channel,
- ם a translating member (or lower gland) secured to a longitudinal wall of the housing and bounding a variable volume region of the fluid channel,
- a post having a lumen terminating at a distal head of the post and biased in the ם proximal direction by the lower gland when in the closed mode, and

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NP Medical Premarket Notification – 510(k) K 100 Needle Free Connector SN000 Page 3 of 5

- an upper seal having a sealing ring and secured to the longitudinal wall of the housing, the sealing ring contacting the distal head of the post when in the closed mode to prevent flow through the fluid channel,
- Moving components within the assembly are lubricated with silicone oil.

#### 4.0 PREDICATE DEVICES

The K100 Neutral Displacement Needle Free Connector is substantially equivalent to the following predicate products.

Table 2: Predicate Device

| Product | Cleared Predicate Product k number |
|-------------------------------------------------|------------------------------------|
| NP Medical Capless Needleless Luer<br>Connector | K973916 |

#### 5.0 COMPARISON OF DEVICE UNDER REVIEW AND ITS PREDICATES

| Comparison<br>Element -<br>Similarities | (Subject devices)<br>K100 Neutral Displacement Needle<br>Free Connector | (Predicate device)<br>Capless Needleless Luer Connector |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k holder | NP Medical, Inc | NP Medical, Inc. |
| Manufacturer | NP Medical, Inc. | NP Medical, Inc. |
| Indication for/<br>Intended Use | The K100 Neutral Displacement<br>Connector is a single patient use, sterile,<br>non-pyrogenic device for needleless<br>access to the IV line and/or IV catheter<br>during IV therapy. The K100 connector<br>can be used for direct injection,<br>intermittent infusion, continuous<br>infusion, or aspiration. | The Capless Luer Activated Valve,<br>incorporating a luer activated valve, is<br>intended for use in facilitating<br>needleless fluid delivery and may be<br>swabbed with antiseptic just prior to<br>use, thereby eliminating the need for<br>capping between uses. |
| Displacement<br>Type | Neutral | Negative |
| Luer connector | ISO luer | ISO luer |
| Multiple<br>Activations | 96 intermittent | 96 intermittent |
| Indwell | 96 hours | 96 hours |
| Chemical<br>Compatibility | Lipids, Alcohol, CHG | Lipids, Alcohol |

Table 3: Comparison of proposed new device and its predicates.

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NP Medical Premarket Notification - 510(k) K100 Needle Free Connector SN000 Page 4 of 5

| Comparison<br>Element -<br>Similarities | (Subject devices)<br>K100 Neutral Displacement Needle<br>Free Connector | (Predicate device)<br>Capless Needleless Luer Connector |
|-----------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------|
| Pressure<br>Rating | 325 psi | > 60 psi |
| Priming<br>Volume | 0.12 mL | 0.25 mL |
| Microbial<br>inaress Test | Pass | Pass |
| Sterile | Yes | Yes |
| Packaging<br>Type | Blister | Blister |
| Materials | PC/Silicone (no latex or DEHP) | PC/Silicone (no latex or DEHP) |

Table 3: Comparison of proposed new device and its predicates.

As demonstrated in Table 3, there are equivalent features and functional uses between the devices. Materials are tested to the latest ISO 10993 standards. Differences are in displacement, maximum pressure, and priming volume. These differences do not introduce any new safety or efficacy risks to the patient.

#### 6.0 PERFORMANCE TESTING - BENCH

NP Medical has conducted risk analyses and design verification/validation tests based on the result of these analyses.

All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use. The following bench tests were conducted to evaluate the design on the functional performance of the K100 Neutral Displacement Needle Free Connector.

Verification and Validation Testing conducted by NP Medical .All tests met acceptance criteria.

| Test Name |
|-----------------------------------|
| Air Bolus and Bubble Free Priming |
| Repeat Insertion |
| Blood Flushing Evaluation |
| Bolus Back Pressure |
| Docking Stability |
| Flow Rate |
| Fluid Displacement |

Table 4: K100 Verification and Validation Testing

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| Test Name |
|--------------------------------------------------------|
| Gland Height Determination |
| Hydraulic Burst Leak |
| ISO 594 Test Methods |
| Lipid Resistance |
| Priming Volume |
| Residual Volume |
| Stress Resistance to Swabbing Chemicals (IPA and CHG). |
| Torque Testing |

In addition to the Bench testing, NP Medical has successfully conducted Microbial Ingress testing, Sterilization Validation and Packaging/Shelf Life Validation.

#### 7.0 CONCLUSION

- 7.1 The K100 Neutral Displacement Needle Free Connector is substantially equivalent to the identified predicate system based on the indication for use, design features, operating principles, performance tests and material composition.

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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three waves emanating from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## April 3, 2013

Mr. Luis J Maseda General Manager NP Medical Incorporated 101 Union Street CLINTON MA 01501

Re: K130023

Trade/Device Name: K100 Neutral Displacement Needle Free Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 31, 2012 Received: January 3, 2013

Dear Mr. Maseda:

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.

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Page 2 - Mr. Maseda

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

for

Theta
Uronita.

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Indication for Use

510(k) Number (if known): 上ろしの23

Device Name: K100 Neutral Displacement Needle Free Connector

Indication for Use:

The K100 Neutral Displacement Needle Free Connector is a single patient use device for needleless access to the IV line and/or IV catheter during IV therapy. The K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

Prescription Use × (21 CFR Part 801 Subpart D) and/or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 2013.04.03 11:40:56 -04'00'

Division Sign-Off Office of Device Evaluation

K130023 510(k)

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