(119 days)
Not Found
No
The device description focuses on mechanical and material properties, and the safety mechanism is described as passively activated by the clinician, not through any computational or learning process. There are no mentions of AI, ML, or related concepts in the provided text.
No.
The device is a safety introducer needle used for guidewire introduction and to reduce injuries; it does not treat a disease or condition.
No
The device is an introducer needle used for percutaneous procedures, specifically for guidewire introduction. Its primary function is to facilitate the insertion of a guidewire, and it incorporates safety features to prevent needlestick injuries. There is no mention of it diagnosing any condition or disease.
No
The device description clearly outlines physical components made of stainless steel and plastic, including a trocar/needle, hub, sheath, and safety guard. It is a physical medical device, not software.
Based on the provided text, the LumiLoc™ Safety Introducer Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "percutaneous procedures utilizing a sheathed introducer trocat/needle for guidewire introduction during percutaneous gastrointestinal procedures." This describes a surgical or interventional procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description focuses on the physical components of a needle and sheath designed for insertion into the body. There is no mention of reagents, calibrators, controls, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Measuring or detecting substances in a biological sample (blood, urine, tissue, etc.).
- Providing information for diagnosis, monitoring, or treatment decisions based on laboratory testing.
- Use in a laboratory setting.
The device is designed to facilitate a medical procedure (guidewire introduction) and incorporates a safety feature to prevent needlestick injuries during that procedure. This falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LumiLocTM 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 LumiLocTM 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 LumiLocTM Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.
Product codes
78 KNT
Device Description
The LumiLocTM 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 LumiLocTM 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 LumiLocTM Safety Introducer Needle incorporates an intuitive easy to use safety guard which is an integral part of the device. The LumiLocTM 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.
LumiLocTM 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 LumiLocTM Safety Introducer Needies will be incorporated into a procedurai tray or kit, packaged and sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, clinical end-user
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
Not Found
Summary of Performance Studies
Comparative testing has been performed on the LumiLocTM Safety Introducer Needles and the predicate devices. Test results indicate that the LumiLocTM Safety Introducer Needles perform in a substantially equivalent manner to the predicate devices. A total of 500 LumiLocTM Safety Introducer Needles were successfully inserted by clinicians into simulated tissue and activated. No sharps injuries or failures of the integral safety guard occurred.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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):
-
- 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.
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.
1
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.
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.
2
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.
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
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K070449
Device Name: LumiLoc™ Safety Introducer Needle Indications for Use:
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.
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_________________________________________________________________________________________________________________________________________________________________