(146 days)
Not Found
No
The device description and performance studies focus on mechanical functionality and do not mention any AI/ML components or data processing.
No
The device is described as a "Medical Tubing Length Reducing Apparatus" intended to manage excess IV tubing length, not to treat or diagnose a medical condition.
No
Explanation: The device is designed to manage the length of IV tubing and does not claim to diagnose any medical conditions or provide diagnostic information. Its function is purely mechanical, addressing a physical issue (excess tubing slack).
No
The device description clearly states it is a physical apparatus made of polystyrene with specific dimensions, designed to physically manipulate IV tubing. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for managing the length of IV tubing used for administering drugs and solutions. This is a physical function related to the delivery of substances into the body, not for examining specimens from the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical mechanism of the device for reducing tubing length and its material. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic, monitoring, or prognostic information
The device is a physical accessory for IV administration sets, designed to improve the practical handling of the tubing.
N/A
Intended Use / 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 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.
Product codes
FPA
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.
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
hospitals and home patient care
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
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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:
-
- Submitter's Identification: Padi-Lock, LLC 5747 Fezzor Rd Farmington, MO 63640
Contact Person: Padi Pettus Tel: 650-567-0061 X304
- Submitter's Identification: Padi-Lock, LLC 5747 Fezzor Rd Farmington, MO 63640
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.
4
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 | |
| 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. | For use with a vascular access device | |
| for the administration of drugs and | ||
| solutions. The Clearlink Luer | ||
| Activated Valve is an in-line | ||
| injection site, which can be connected | ||
| to standard male luer adapters (e.g. | ||
| syringes or sets) for continuous or | ||
| intermittent fluid administration or | ||
| withdrawal of fluids. | ||
| Size/Dimensions | 7.5" x 4.42" x 0.28" | |
| (L x W x H) | Tube Length 92" | |
| Materials | Tube Channel: 0.14" | |
| Does not contact the fluid | ||
| pathway | Tube Outer Diameter (OD): 0.14" | |
| Materials contact Fluid pathway | ||
| Target population | Individuals in hospital or home | |
| care that require the use of an | ||
| IV administration set. | Individuals in hospital or home care | |
| that require the use of an IV | ||
| 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.