PADI-LOCK

K141200 · Padi-Lock, LLC · FPA · Oct 2, 2014 · General Hospital

Device Facts

• Record ID: K141200
• Device Name: PADI-LOCK
• Applicant: Padi-Lock, LLC
• Product Code: FPA · General Hospital
• Decision Date: Oct 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

For use with a vascular access device for the administration of drugs and solutions. The Padi-Lock Medical Tubing Length Reducing Apparatus can be connected to the administration set by snaking the excess tubing through the device to shorten the length of the tubing. The device is intended to be used in hospitals and home patient care where IV tubing is used.

Device Story

Padi-Lock is a mechanical accessory for IV administration sets; designed to manage excess tubing length. Device consists of a polystyrene frame with a channel; user snakes IV tubing through channel to reduce slack by up to 32 inches. Used in hospitals and home care settings; operated by clinicians or patients. Device hangs freely on tubing; does not contact fluid pathway. By securing excess tubing, device prevents tangling and tripping; reduces risk of patient injury or discomfort. Does not function as a standalone device; intended to improve safety and convenience of existing IV setups.

Clinical Evidence

No clinical data. Bench testing only; performance testing protocols confirmed device functionality and adherence to predetermined acceptance criteria.

Technological Characteristics

Polystyrene construction; dimensions 7.5" x 4.42" x 0.28"; tube channel 0.14" diameter. Mechanical accessory; non-patient contacting; non-fluid path contacting. Standalone mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for individuals in hospital or home care settings requiring the use of an IV administration set for the administration of drugs and solutions.

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

• Clearlink Luer Activated Valve, IV administration and IV extension sets, with the Clearlink Luer Activated Valve (K112893)

Submission Summary (Full Text)

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

October 2, 2014

Padi-Lock, Limited Liability Company C/O Ms. Maria F. Griffin Official Correspondent 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K141200

Trade/Device Name: Padi-Lock Medical Tubing Length Reducing Apparatus Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 4, 2014 Received: September 4, 2014

Dear Ms. Griffin:

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 - Ms. Griffin

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Industry/default.htm.

Sincerely yours,

Susan Runno, DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

Device Name

Padi-Lock Medical Tubing Length Reducing Apparatus

Indications for Use (Describe)

For use with a vascular access device for the administration of drugs and solutions. The Padi-Lock Medical Tubing Length Reducing Apparatus can be connected to the administration set by snaking through the device to shorten the length of the tubing. The device is intended to be used in hospitals and home patient care worere IV tubing is used.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

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## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

- 1. Submitter's Identification: Padi-Lock, LLC 5747 Fezzor Rd Farmington, MO 63640
Contact Person: Padi Pettus Tel: [phone] X304

Date Summary Prepared: April 7, 2014

- Trade Name of the Device: Padi-Lock 2.
#### 3. Common or Usual Name: Intravascular Administration Set

#### 4. Classification:

Regulation: 21 CFR 880.5440 Product Code: FPA

#### ട്. Predicate Device Information:

Clearlink Luer Activated Valve, IV administration and IV extension sets, with the Clearlink Luer Activated Valve, K112893

#### 6. Device Description:

The Padi-Lock was designed to control the excess length in IV tubing. This patented device efficiently reduces the slack in tubing that can get tangled or tripped on causing additional patient injury or discomfort. The Padi-Lock hangs freely on the IV tubing. The Padi-lock efficiently reduces up to 32 inches of excess IV tubing. The Padi-Lock is made of polystyrene. The device dimensions are 7.5'' x 4.42'' x 0.28" (L x W x H) with a tube channel designed to fit the outer dimension of IV tubing (0.14"). The tubing is snaked through the device so that it securely sits in the channel for unobstructed flow of the fluid through the tubing.

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#### 7. Intended Use:

For use with a vascular access device for the administration of drugs and solutions. The Padi-Lock Medical Tubing Length Reducing Apparatus can be connected to the administration set by snaking the excess tubing through the device to shorten the length of the tubing. The device is intended to be used in hospitals and home patient care where IV tubing is used.

| Item | Padi-Lock | Baxter |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | For use with a vascular access<br>device for the administration of<br>drugs and solutions. The Padi-<br>Lock Medical Tubing Length<br>Reducing Apparatus can be<br>connected to the administration<br>set by snaking the excess<br>tubing through the device to<br>shorten the length of the<br>tubing. The device is intended<br>to be used in hospitals and<br>home patient care where IV<br>tubing is used. | For use with a vascular access device<br>for the administration of drugs and<br>solutions. The Clearlink Luer<br>Activated Valve is an in-line<br>injection site, which can be connected<br>to standard male luer adapters (e.g.<br>syringes or sets) for continuous or<br>intermittent fluid administration or<br>withdrawal of fluids. |
| Size/Dimensions | 7.5" x 4.42" x 0.28"<br>(L x W x H) | Tube Length 92" |
| Materials | Tube Channel: 0.14"<br>Does not contact the fluid<br>pathway | Tube Outer Diameter (OD): 0.14"<br>Materials contact Fluid pathway |
| Target population | Individuals in hospital or home<br>care that require the use of an<br>IV administration set. | Individuals in hospital or home care<br>that require the use of an IV<br>administration set. |

#### 8. Technological Comparison to Predicate Devices:

The Padi-Lock is designed as an accessory to the IV administration set and cannot be used as a stand alone device. The difference of materials does not impact the safety and effectiveness of the device because the device is not used directly on the patient and does not come in contact with the fluid path. The dimension of the channel of the Padi-Lock is the same as the OD of the tubing.

### Discussion of Non-Clinical Tests Performed for Determination of Substantial 9. Equivalence are as follows:

Bench testing was performed to assess functionality of the Padi-Lock. The Padi-Lock device was tested according to the User/Performance Testing Protocols. The devices met the requirements of the predetermined acceptance criteria. All devices passed the test

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#### 10. Discussion of Clinical Tests Performed:

Clinical testing was not performed.

#### Conclusions: 11.

Based on the information provided in this submission we conclude that the Padi-Lock is substantially equivalent to the predicate and is safe and effective for its intended use.