The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure.

Device Description

The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.

AI/ML Overview

The provided text describes a medical device, the "Mini-Midline™ Extended Dwell Safety Catheter," and its substantial equivalence to predicate devices, but does not include acceptance criteria for a study demonstrating AI/algorithm performance. The document focuses on regulatory approval (510(k) submission) for a physical medical device, not a software algorithm.

Therefore, most of the requested information regarding AI/algorithm performance (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, MRMC studies, standalone performance) cannot be extracted from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not present for an AI/algorithm-based device. The document lists "Technical Characteristics" and "Performance Data" for the physical catheter.

Acceptance Criteria (for AI)	Reported Device Performance (for AI)
Not applicable (device is a physical catheter)	Not applicable (device is a physical catheter)

However, the document does list technical characteristics and performance data for the physical device:

Technical Characteristics and Performance Data (for the physical catheter):

Characteristic/Test	Description/Result
Function	Intravenous catheter
Anatomical Site	Peripheral vasculature
Duration of use	< 30 days
Access method	Venipuncture, via needle
Catheter Gauge	20
Sharps injury prevention feature	Yes
How provided	Sterile, disposable (single use)
Performance Testing	- Visual Inspection - Leak Testing - Flow Rate Testing - Tensile Strength - Corrosion Resistance - Flexural Integrity - Insertion Force - User Evaluation (simulated use)
Conclusion from Performance Data	All necessary verification and validation testing has been performed... to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not described. The document mentions "test units representative of finished devices" for physical testing, but not a dataset for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study was not done, as this document describes a physical medical device, not an AI or algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This document describes a physical medical device, not an AI or algorithm, so standalone performance for an algorithm is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Cannot be determined. This information pertains to a study evaluating an AI/algorithm, which is not described. For the physical device, "ground truth" would relate to its physical properties meeting design specifications through the listed performance tests.

8. The sample size for the training set:

Cannot be determined. This information pertains to an AI/algorithm development, which is not described.

9. How the ground truth for the training set was established:

Cannot be determined. This information pertains to an AI/algorithm development, which is not described.

Summary

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K130≤18

Section 6

510(k) Summary of Safety and Effectiveness

6. 510(k) Summary of safety and effectiveness

APR 3 0 2013

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

APPLICANT:	Luther NeedleSafe Products, Inc.
DATE PREPARED:	February 21, 2013
CONTACT PERSON:	Rebecca K PineLuther NeedleSafe Products, Inc.7 Rimani DriveMission Viejo, CA 92692Phone: (760) 809.5178
TRADE NAME:	Mini-Midline™ Extended Dwell Safety Catheter
COMMON NAME:	Intravascular Catheter
CLASSIFICATIONNAME:	Catheter, Intravascular, Therapeutic, Short-Term, less than 30days
DEVICECLASSIFICATION:	Class 2, per 21 CFR 880.5200
PRODUCT CODE	FOZ
PREDICATE DEVICES:	PowerGlide Midline Catheter (K121073)Rapid Intravascular Start System (K112347)BD Incyte Autoguard IV Catheter (K110443)

Substantially Equivalent To:

The Mini-Midline Extended Dwell Safety Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the PowerGlide Midline Catheter, Rapid Intravascular Start System and the BD Insyte Autoguard IV Catheter.

Description of the Device Subject to Premarket Notification:

Luther NeedleSafe Products, Inc. Mini-Midline™ Extended Dwell Safety Catheter

Page 11 of 58 Premarket Notification

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Indication for Use:

Technical Characteristics:

The Mini-Midline™ Extended Dwell Safety Catheter has similar physical and technical characteristics to the predicate devices as shown in the table below.

	Mini-Midline™Extended DwellSafety Catheter	PowerGlideMidlineCatheter(K121073)	RapidIntravascularStart System(K112347)	BD InsyteAutoguard IVCatheter(K110443)
Function	Intravenous catheter	SAME	SAME	SAME
Anatomical Site	Peripheralvasculature	SAME	SAME	SAME
Duration of use	< 30 days	SAME	SAME	SAME
Access method	Venipuncture, vianeedle	SAME	SAME	SAME
Catheter Gauge	20	20	222018	141618202224
Sharps injurypreventionfeature	Yes	SAME	SAME	SAME
How provided	Sterile, disposable(single use)	SAME	SAME	SAME

Performance Data:

All necessary verification and validation testing has been performed for the Mini-Midline™ Extended Dwell Safety Catheter to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Testing included:

Visual Inspection .
Leak Testing .
Flow Rate Testing ●
Tensile Strength ●
Corrosion Resistance .
. Flexural Integrity
Insertion Force ●
. User Evaluation (simulated use)

Luther NeedleSafe Products, Inc. Mini-Midline™ Extended Dwell Safety Catheter

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Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Mini-Midline™ Extended Dwell Safety Catheter is determined by Luther NeedleSafe Products, Inc. to be substantially equivalent to existing legally marketed devices.

Luther NeedleSafe Products, Inc. Mini-Midline™ Extended Dwell Safety Catheter

Page 13 of 58 Premarket Notification

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Public Health Service

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

· April 30, 2013

Ms. Rebecca K. Pine Luther NeedleSafe Products, Incorporated 7 Rimani Drive MISSION VIEJO, CA 92692

Re: K130518

Trade/Device Name: Mini-Midline™ Extended Dwell Safety Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 22, 2013 Received: March 1, 2013

Dear Ms. Pine:

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 Eederal Register.

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Page 2 - Ms. Pine

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 devicerelated 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.

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

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1. Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __ K130518

Device Name: Mini-Midline™ Extended Dwell Safety Catheter

Indications for Use:

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sajjad
Syed

Digitally signed DN:
c=US
o=
ou=FDA, ou=
0.9.2342.1920
Date: 2013.04.

by Saijad H. Syed IS Government outsHHS onle, cn=Saiiad H. Sved. 00.100.1.1=2000601742

slon Sian-Off) of Anesthestology. Coneral Hospital Infection Control. Dental Devi

510(k) Number: K130118

Page of

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).