SecureLoc™ Safety Introducer Needles are intended to be used for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLoc™ Safety Introducer Needles are intended to be used as integral safety procedure needles for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. The SecureLoc™ Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and reduces the risk of accidental needlestick injuries by locking a safety guard covering the needle tip. The safety guard can be activated over stylettes, obturators, and guidewires. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical endusers. May be used in any appropriate patient population.

AdvancIntroducer™ Introducer Needles are intended to be used with those patients requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures. Will be marketed as bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical endusers. May be used in any appropriate patient population.

Device Description

The AdvancIntroducer™ needles consist of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The hub has a bevel-up orientation indicator. The hub has been designed to provide the end-user excellent ergonomic tactile balance and stability. The AdvancIntroducer™ needles are available in one-wall with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature or a specialty coating to enhance available war and with oneedles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. AdvancIntroducer™ needles will be marketed to the clinical end-user as sterile, nonpyrogenic, and single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The AdvancIntroducer™ will be incorporated into the procedure kit, packaged and sterilized.

SecureLoc™ Safety Introducer Needles have all the same components as the AdvancIntroducer™ and in addition, incorporates an intuitive easy to use safety guard which is an integral part of the device. SecureLoc™ Safety Introducer Needles are designed for common Introducer needle lengths and gauges. Obturators and stylettes are appropriately available. Stylette handles have an incorporated key to align to the cutting bevel. The SecureLoc™ Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and locks a safety guard covering the needle tip. The SecureLoc™ Safety Introducer Needle's easy to use intuitive safety guard reduces the risk of accidental needlestick injuries by shielding the needle tip. A visual, tactile feel, and/or audible confirmation of the locking component over the needle confirms lockout of the safety guard over the needle. The sharps injury prevention guard cannot be deactivated and remains protective through disposal into a sharps container. The safety guard can be activated over stylettes, obturators, and guidewires. SecureLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile, non-pyrogenic, single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The SecureLoc™ Safety Introducer will be incorporated into the procedure kit, which is then packaged and sterilized.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the SecureLoc™ Safety Introducer Needles, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence: Device performs in a substantially equivalent manner to predicate devices.	"Test results indicate that the AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles perform in a substantially equivalent manner." (Section: SUMMARY OF PERFORMANCE TESTING)
Needlestick Injury Prevention: - Safety guard automatically senses the end of the needle and locks over the tip. - Reduces the risk of accidental needlestick injuries. - Lock-out can be confirmed visually, tactilely, and/or audibly. - Safety guard cannot be deactivated and remains protective through disposal. - Safety guard can be activated over stylettes, obturators, and guidewires.	- "The safety guard automatically senses the end of the needle and locks a safety guard covering the needle tip." - "Reduces the risk of accidental needlestick injuries by shielding the needle tip." - "A visual, tactile feel, and/or audible confirmation of the locking component over the needle confirms lockout." - "The sharps injury prevention guard cannot be deactivated and remains protective through disposal into a sharps container." - "The safety guard can be activated over stylettes, obturators, and guidewires." - Simulated Use Study: "No sharps injuries or failures of the integral needlestick prevention guard/safety guard occurred."
Sterility & Pyrogenicity: Device to be marketed as sterile, non-pyrogenic.	"SecureLoc™ Safety Introducer Needles will be marketed... as sterile, non-pyrogenic, single use devices." (Implied acceptance by the FDA for this claim and as part of the overall substantial equivalence determination).
Material Compatibility: Similar in function, materials and use to predicate devices.	"The AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles are similar in function, materials and use as the predicate Merit Medical Introducer needle devices." (Section: TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 500 SecureLoc™ Safety Introducer Needles were used in the simulated use study.
Data Provenance: The data is prospective, generated from a "simulated use study" specifically conducted for this submission. The country of origin is not explicitly stated, but it is implied to be generated within the US by Specialized Health Products®, Inc. as part of their 510(k) submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document states "clinicians" performed the insertions in the simulated use study.

Number of Experts: Not explicitly stated as a specific number of individual experts or clinicians. It simply refers to "clinicians" in the plural.
Qualifications of Experts: The specific qualifications (e.g., years of experience, specialty) of these clinicians are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the simulated use study. The assessment of "no sharps injuries or failures" appears to have been a direct observation during the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a physical medical device (introducer needle) and not an AI/software-as-a-medical-device (SaMD) that would involve human "readers" or AI assistance in interpretation.

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

No standalone algorithm performance study was done. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the simulated use study was the direct observation of events and outcomes during the simulated procedure. Specifically, the ground truth checked for:

Successful insertion into simulated tissue.
Activation of the safety mechanism.
Absence of sharps injuries.
Absence of failures of the safety guard.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development. The device design and materials were likely based on general engineering principles and comparison to existing predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no training set for an AI algorithm. The "ground truth" equivalent for the development of this device would be its adherence to design specifications, material properties, and functional requirements, which were likely evaluated through engineering tests (referred to as "Comparative testing" and "material testing").

Summary

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K050023

FEB 1 8 2005

Lot 3

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for the SecureLoc™Safety Introducer Needles

SUBMITTER:

Specialized Health Products®, Inc. 585 West 500 South, Suite 200 Bountiful, Utah 84010

ESTABLISHMENT REGISTRATION NUMBER: 1723684

CONTACT:

Mark Nelson Director, Quality and Regulatory Affairs Telephone: 801-298-3360 Fax: 801-298-1759 Email: marknelson@shpi.com

DATE PREPARED:

1/4/2005

NAME OF MEDICAL DEVICE:

Classification Name: Catheter Introducer Common/Usual Name: General Percutaneous Introducer Needles Proprietary Name: AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles

DEVICE CLASSIFICATION:

Classification Panel: General Hospital Class: II Procode: DYB Regulation Number: 21 CFR 870.1340

STATEMENT OF SUBSTANTIAL EQUIVALENCE (Predicate Device References):

1. Safety Introducer Needles (K030135), B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown, PA 18109.
Majestik™ Angiographic Introducer Needles (pre-amendment), Merit Medical 2. Systems, Inc., 1600 West Merit Parkway South Jordan, Utah 84095.

DEVICE DESCRIPTION:

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available with and without an echogenic feature or a specialty coating to enhance available war and with oneedles are available in a range of wall thicknesses, gauges and lengths to match the end-user need.

AdvancIntroducer™ needles will be marketed to the clinical end-user as sterile, nonpyrogenic, and single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The AdvancIntroducer™ will be incorporated into the procedure kit, packaged and sterilized.

The SecureLoc™ Safety Introducer Needle's safety engineered integral safety guard is advanced by the clinician. The safety guard automatically senses the end of the needle and locks a safety guard covering the needle tip. The SecureLoc™ Safety Introducer Needle's easy to use intuitive safety guard reduces the risk of accidental needlestick injuries by shielding the needle tip. A visual, tactile feel, and/or audible confirmation of the locking component over the needle confirms lockout of the safety guard over the needle. The sharps injury prevention guard cannot be deactivated and remains protective through disposal into a sharps container. The safety guard can be activated over stylettes, obturators, and guidewires.

SecureLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile, non-pyrogenic, single use devices. Additionally, the device will be marketed as the safety procedure needle in procedure trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The SecureLoc™ Safety Introducer will be incorporated into the procedure kit, which is then packaged and sterilized.

INTENDED USE:

Both the AdvancIntroducer™ and the SecureLoc™ Safety Introducer Needles are intended to be used for those patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures.

The AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles will be marketed as both bulk non-sterile single use devices to procedural kit manufacturers and also as sterile, non-pyrogenic, single use devices to clinical end-users. The AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles may be used in any appropriate patient population. Page 15 of 72 Confidential

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TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

I is Specialized Health Products®, Inc.'s conclusion that the AdvancIntroducer™ and the It is Specialized Health Producer Needles are substantially equivalent to the following Secures: Safety Introducer Needles (K030135), B. Braun Medical, Inc., 901 Marcon acvices: Bajery Infroadco (1188) (1188) 118 Angiographic Introducer Needles (pre-Boutevard, Thentown, 11 1 10167 uns, Inc., 1600 West Merit Parkway South Jordan, Utah 84095

A summary of the key technological comparisons follows:

The AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles are similar in . r the havane firstion, materials and use as the predicate Merit Medical Introducer needle devices.
The SecureLoc™ Safety Introducer Needles have a safety guard that locks a safety . guard over the needle tip after the needle is removed from the patient, as does the B. Braun predicate device.
The SecureLoc™ Safety Introducer Needle's safety guard lock-out can be confirmed . by visual means, tactile feel and/or audible means, as does the B. Braun predicate device cited in this submission.

SUMMARY OF PERFORMANCE TESTING:

Comparative testing has been performed on the AdvancIntroducer™ and the SecureLoc™ Safety Introducer Needles and the predicate devices. Test results indicate that the AdvancIntroducer™ and SecureLoc™ Safety Introducer Needles perform in a substantially equivalent manner.

SUMMARY OF SIMULATED USE STUDY:

A total of 500 SecureLoc™ Safety Introducer Needles were successfully inserted by clinicians into simulated tissue and activated. No sharps injuries or failures of the integral needlestick prevention guard/safety guard occurred.

CONCLUSION:

The material testing and simulated use data demonstrate that the AdvancIntroducer™ and the SecureLoc™ Safety Introducer Needle are safe and effective for their intended use, comply with medical device standards, and are substantially equivalent to:

Safety Introducer Needles (K030135), B. Braun Medical, Inc., 901 Marcon Boulevard, . Allentown, PA 18109.
Majestik™ Angiographic Introducer Needles (pre-amendment), Merit Medical Systems, . Inc., 1600 West Merit Parkway South Jordan, Utah 84095.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that appears to be three overlapping human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2005

Mr. Mark Nelson Director, Quality and Regulatory Affairs Specialized Health Products® Incorporated 585 West 500 South #200 Bountiful, Utah 84010

Re: K050023

Trade/Device Name: AdvancIntroducer™ Introducer Needles and SecureLoc™ Safety Introducer Needles Regulation Number: 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: January 3, 2005 Received: January 6, 2005

Dear Mr. Nelson:

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 mendments, 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 approvisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wr.), it may be backed to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear. be foundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Nelson

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DTC 3 lostained on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal states and registered to registerial woulding, but not limited to: registration You must comply with an the Fee requirements) ; good manufacturing practice and ifsing (21 CFR 1 art 007), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgan mading of substantial equivalence of your device to a premarket notification. The PDF miling of basesiation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice to: Jour de at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of 01618-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 1 of 2

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SecureLocTM Safety Introducer Needles

Indications for Use:

SecureLoc™ Safety Introducer Needles are intended to be used for those patients . SecureDoc - Burety marcedures utilizing an introducer needle for guidewire requiring persualleous it placement of catheters or other introducer needle required medical procedures.
The SecureLoc™ Safety Introducer Needles are intended to be used as integral . I he Secureboo - Baroy thase patients requiring percutaneous procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures.
or other matten Safety Introducer Needle's safety engineered integral safety guard . is advanced by the clinician. The safety guard automatically senses the end of the 15 advanced of the risk of accidental needlestick injuries by locking a safety necode and readed tip. The safety guard can be activated over stylettes, obturators, and guidewires.
Will be marketed as bulk non-sterile single use devices to procedural kit . will be manifecturers and also as sterile, non-pyrogenic, single use devices to clinical endusers.
May be used in any appropriate patient population. .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AdvancIntroducer™ Introducer Needles

Indications for Use:

AdvancIntroducer™ Introducer Needles are intended to be used with those patients . requiring percutaneous entry procedures utilizing an introducer needle for guidewire placement for subsequent placement of catheters or other introducer needle required medical procedures.
Will be marketed as bulk non-sterile single use devices to procedural kit . manufacturers and also as sterile, non-pyrogenic, single use devices to clinical endusers.
May be used in any appropriate patient population. .

Teresa Perez Ott

sion Sich-Off) island City-Office Infogy, General Hospital, noution Control, Dental Devices

10:50 Number:__ 154544 27

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).