The LumiLoc™ Safety Introducer Needle is intended to be used for percutaneous procedures utilizing a sheathed introducer trocat/needle for guidewire introduction during percutaneous gastrointestinal procedures.

The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath.

The LumiLoc™ Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.

Device Description

The LumiLoc™ Safety Introducer Needle consist of a stainless steel trocar/needle with a colored translucent hub and a colored translucent safety guard, a sheath attached to a translucent hub having a standard female Luer lock hub connector. The trocar/needle hub has a bevel-up orientation indicator. The sheath hub utilizes a phosphorescent material. The LumiLoc™ Safety Introducer Needle's sheath hub has an integral Seldinger shield. The stainless steel trocars/needles have a specialty coating to enhance percutaneous entry.

The LumiLoc™ Safety Introducer Needle incorporates an intuitive easy to use safety guard which is an integral part of the device. The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath and helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip. A visual. tactile, or audible confirmation of the locking component over the trocar/needle confirms lockout of the safety guard over the trocar/needle.

LumiLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile single use devices. Additionally, the device will be placed in Percutaneous Endoscopic Gastrostomy (PEG) procedural trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the procedural tray or kit manufacturer. The LumiLoc™ Safety Introducer Needies will be incorporated into a procedurai tray or kit, packaged and sterilized.

AI/ML Overview

The provided text describes the LumiLocTM Safety Introducer Needle and its regulatory submission. It does not contain information about an AI/ML device or its performance characteristics. This device is a physical medical instrument, not a software algorithm. Therefore, many of the requested categories related to AI/ML device evaluations (e.g., sample size for training set, MRMC studies, ground truth establishment, number of experts for ground truth) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the study that "proves" it meets them, based on the context of a 510(k) submission for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description (Implied)	Reported Device Performance
Safety Guard Functionality	The integral safety guard must activate upon removal of the trocar/needle and lock over the tip to reduce needlestick injuries.	500 LumiLoc™ Safety Introducer Needles were successfully activated.
Injury Prevention	The device should prevent sharps injuries (specifically related to the safety guard).	No sharps injuries occurred during the simulated use study.
Failure Rate	The integral safety guard should not fail during use.	No failures of the integral safety guard occurred.
Successful Insertion	The device should allow for successful insertion into simulated tissue.	500 LumiLoc™ Safety Introducer Needles were successfully inserted.
Substantial Equivalence	The device must perform in a substantially equivalent manner to predicate devices regarding safety and effectiveness for its intended use.	Test results indicate substantial equivalence to predicate devices.

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

Sample Size for Test Set: 500 LumiLoc™ Safety Introducer Needles.
Data Provenance: The study was a "simulated use study." This implies a controlled laboratory or clinical simulation environment rather than actual patient data. The country of origin is not specified, but the submission is to the US FDA, so the testing was likely conducted in the US or under US regulatory standards. It's prospective in the sense that the testing was performed specifically for this submission.

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

Number of Experts: Not explicitly stated, but the study involved "clinicians" performing the simulated insertions and activations. The exact number of clinicians is not provided.
Qualifications of Experts: Described as "clinicians." Specific qualifications (e.g., years of experience, specialty) are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not described. This was a direct performance test where the device's physical function (activation, no injuries, no failures) was observed. There isn't a "ground truth" to adjudicate in the typical sense of subjective interpretations. The outcomes (e.g., "no sharps injuries," "no failures") are direct observational results.

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

MRMC Study: No, this is not an AI/ML device. This type of study is not applicable.

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

Standalone Performance: Not applicable, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is the objective observation of the device's physical performance during the simulated use study.
- Successful insertion: Observed directly.
- Safety guard activation: Observed directly.
- Lack of sharps injuries: Observed directly.
- Lack of failures: Observed directly.
- The "material testing" mentioned also contributed to proving substantial equivalence, suggesting engineering specifications and quality control data likely formed part of the ground truth for material properties.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML model that requires a training set. The development process would involve iterative design and testing, but not a "training set" in the computational sense.

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

How Ground Truth for Training Set Was Established: Not applicable.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92)

for the LumiLocTM Safety Introducer Needle

SUBMITTER:

Specialized Health Products® International, InqujN 1 4 2007
585 West 500 South, Suite 200 585 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:

2/14/2007

NAME OF MEDICAL DEVICE:

Classification Name: Tube, Gastrointestinal (and Accessories) Common/Usual Name: Safety Percutaneous Endoscopic Gastrostomy Introducer Proprietary Name: LumiLocTM Safety Introducer Needle

DEVICE CLASSIFICATION:

Classification Panel: Gastrointestinal/Urology Class: II Product Code: 78 KNT Regulation Number: 21 CFR 876.5980

STATEMENT OF SUBSTANTIAL EQUIVALENCE (Predicate Device References):

1. SecureLoc™Safety Introducer (K050023), Specialized Health Products® International, Inc., 585 W. 500 S., Bountiful, UT 84010.
1. Modified TFX Medical Safety Needle with Introducer (K043258), Teleflex Medical, Inc., 50 Plantation Drive, Tall Pines Park, Jaffrey, NH 03452.

DEVICE DESCRIPTION:

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INTENDED USE:

The device is intended to be used for guidewire introduction during percutaneous gastrointestinal procedures.

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

It is Specialized Health Products® International, Inc.'s conclusion that the LumiLooTM Safety Introducer Needles are substantially equivalent to the following devices: SecureLoc™ Safety Introducer (K050023). Specialized Health Products® International, Inc., 585 W. 500 S., Bountiful, UT 84010 and the Modified TFX Medical Safety Needle with Introducer (K043258), Teleflex Medical, Inc., 50 Plantation Drive, Tall Pines Park, Jaffrey, NH 03452.

A summary of the key technological comparisons follows:

. The LumiLoc™ Safety Introducer Needles are similar in clinical use, function. materials and use as compared to both predicate percutaneous introduction devices.
The LumiLoc™ Safety Introducer Needles and the SecureLoc™ Safety Introducer . predicate device use the same safety technology - made by the same company (Specialized Health Products® International. Inc.) - to lock a safety guard over the trocar/needle tip after the trocar/needle is removed from the patient. The TFX predicate also utilizes a safety mechanism to protect the trocar/needle tip.
The LumiLoc™ Safety Introducer Needle's safety guard lock-out can be confirmed . by visual, tactile or audible means, as do both predicate devices cited in this submission.

SUMMARY OF PERFORMANCE TESTING:

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

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SUMMARY OF SIMULATED USE STUDY:

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

CONCLUSION:

The material testing and simulated use test data demonstrate that the LumiLoc™ Safety Introducer Needle is safe and effective for its intended use, comply with medical device standards, and is substantially equivalent to:

SecureLoc™ Safety Introducer (K050023), Specialized Health Products® . International, Inc., 585 W. 500 S., Bountiful, UT 84010.
Modified TFX Medical Safety Needle with Introducer (K043258), Teleflex Medical, . Inc., 50 Plantation Drive, Tall Pines Park, Jaffrey, NH 03452.

<070449 PAGE 3 OF 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 1 4 2007

Mr. Mark Nelson Director, RA/QA Specialized Health Products International, Inc. 586 West 500 South, #200 SALT LAKE UT 84010

Re: K070449

Trade/Device Name: Lumiloc Safety Introducer Needle Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 29, 2007 Received: May 30, 2007

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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular and contains the text "1906-2006" at the top. The letters "FDA" are in the center of the logo, with the word "Centennial" below them. There are three stars below the word "Centennial". The text "Protecting and Promoting Public Health" is at the bottom of the image.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx 21 CFR 884 xxxx 21 CFR 892.xxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.btml

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K070449

Device Name: LumiLoc™ Safety Introducer Needle Indications for Use:

The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath.

The LumiLoc™ Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.

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)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.