(67 days)
The D.A.R.T. Pro Handle and X-TRACTOR Tip are solely intended for use in the acquisition, removal and storage of darts projected from stun guns and lodged in human tissue and/or clothing. The device is not intended for use as a medical sharps container.
The reusable D.A.R.T. Pro Handle and detachable, single-use only X-TRACTOR Tip (including a safety cap) comprise the two components of the device. Each of these components is described generally below.
- D.A.R.T. Pro Handle: A reusable handle component that is uniquely designed for the secure attachment (and removal post-use) of the X-TRACTOR Tip. The D.A.R.T. Pro Handle allows the user to hold, control and position the assembled product as required for stun gun dart acquisition and removal within the X-TRACTOR Tip. The D.A.R.T. Pro Handle includes a switch at the top of the handle to activate an internal LED light source to illuminate the X-TRACTOR Tip to ease device use in darkened environments. The LED light requires only a standard 9-volt battery, which the user can easily replace as needed.
- X-TRACTOR Tip: A single-use, detachable stun gun dart containment tip specifically designed to securely house up to two stun gun darts. In use, the X-TRACTOR Tip is placed over the stun gun dart and advanced to lock the dart into a sliding tip collet. The D.A.R.T. Pro Handle is then pulled to remove the dart. The external button on the tip collet is then pressed to slide the tip collet and secure the removed dart within the X-TRACTOR Tip. Following removal of up to two stun gun darts, the safety cap is press-fit over the X-TRACTOR Tip to securely house the darts within the X-TRACTOR Tip. Once placed, the safety cap cannot be removed from the X-TRACTOR Tip. The capped X-TRACTOR Tip is then removed from the D.A.R.T. Pro Handle, placed within a zip-seal bag, and the zip-seal bag appropriately identified for provision to law enforcement personnel.
The D.A.R.T. (stun gun Dart-Acquiring and Removal Tool) Pro Kit acceptance criteria and performance are detailed in the provided 510(k) summary. Given that this is a Class II device (sharps container) and not an AI/ML powered device, the typical AI-specific questions are not applicable.
Here's the information parsed from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent performance testing focused on its sharps container functionality for the capped X-TRACTOR Tip, which houses removed stun gun darts.
| Test | Standard | Description | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|---|---|
| Puncture | Health Devices 22ASTM F04.33.01 | Sharps (needle) penetration force | Withstand sharps penetration (prevent penetration/contain sharps) | Pass |
| Leak Resistance | Health Devices 22 | 24 hours filled with water | Prevent leakage when filled with water for 24 hours | Pass |
| Vibration | 49 CFR 178.608 | 1 hour repetitive bounce | Maintain integrity during 1 hour of repetitive bouncing | Pass |
| Free Fall Drop | 49 CFR 178.603 | 5 drops from 3.9 feet | Maintain integrity after 5 drops from 3.9 feet | Pass |
| Stacking | 49 CFR 178.606 | 24 hours under 16.6 lbs | Maintain integrity for 24 hours under 16.6 lbs of weight | Pass |
Note: The formal acceptance criteria for each test are not explicitly stated as numerical values in this summary but are implicit in the "Pass" result, indicating the device met the requirements of the specified standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size (number of units tested) for each performance test. It only states that "Performance testing... included the following sharps container tests conducted on the capped X-TRACTOR Tip".
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are standard engineering/product performance tests, likely conducted in a controlled laboratory environment.
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)
This question is not applicable. The D.A.R.T. Pro Kit is a physical medical device (specifically, a sharps container for stun gun darts), not an AI/ML or diagnostic imaging device that requires expert ground truth for performance evaluation. The "ground truth" for its performance is determined by meeting objective engineering standards (e.g., whether it leaks, punctures, or breaks under specific physical stresses).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in evaluating subjective or complex diagnostic outputs, typically for AI/ML or imaging studies. For physical device performance tests, the outcome (pass/fail) is typically objective and determined by measurement against a standard, not expert consensus on an interpretation.
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
This question is not applicable. MRMC studies are relevant for evaluating the performance of diagnostic systems, particularly those involving human interpretation, often in conjunction with AI. The D.A.R.T. Pro Kit is a physical tool for dart acquisition, removal, and containment, not a diagnostic or AI-powered system, and does not involve human "readers" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The D.A.R.T. Pro Kit is a physical device that is inherently used "human-in-the-loop" for its intended purpose (removing stun gun darts). It does not contain an algorithm or AI component that could be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the D.A.R.T. Pro Kit's performance is objective adherence to physical and mechanical standards for sharps containers, as defined by "Health Devices 22" and "49 CFR" standards. This involves direct measurement and observation of the device's physical properties (e.g., whether it punctures, leaks, or deforms) under specified test conditions, rather than expert consensus, pathology, or outcomes data typically used for diagnostic devices.
8. The sample size for the training set
This question is not applicable. The D.A.R.T. Pro Kit is a mechanical device, not an AI/ML system, and therefore does not have a "training set" in the computational sense. Its design and manufacturing process would involve engineering specifications and quality control, but not data-driven machine learning training.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this type of mechanical device.
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SEP - 2 2008 SECTION 5: 510(k) SUMMARY
In accordance with the requirements of 21 CFR 807.92(c) Global Pathogen Solutions Inc. (hereafter "GPS") has prepared this 510(k) Summary to provide information supporting the substantial equivalence of the D.A.R.T. (stun gun Dart-Acquiring and Removal Tool) Pro Kit, comprised of the reusable D.A.R.T. Pro Handle and the single-use only X-TRACTOR Tip.
General Information:
| Date of Summary Preparation: | June 26, 2008 |
|---|---|
| Name and Address of Manufacturer: | Global Pathogen Solutions Inc.9515 312th AveCamas, Washington 98607 |
| Contact Person: | Carson LinkerPresident/CEOPhone: (503) 679-7612 |
| Trade Name: | D.A.R.T. Pro Kit (D.A.R.T. Pro Handle andX-TRACTOR Tip) |
| Common Name: | Sharps Container |
| Device Classification: | Hypodermic Single Lumen Needle |
| Classification Panel: | General Hospital |
| CFR Reference: | 880.5570 |
| Product Code: | MMK |
| Device Class: | Class II |
Indications for Use: The D.A.R.T. Pro Handle and X-TRACTOR Tip are solely intended for use in the acquisition, removal and storage of darts projected from stun guns and lodged in human tissue and/or clothing. The device is not intended for use as a medical sharps container.
Predicate Devices: The D.A.R.T. Pro Kit, including the D.A.R.T. Pro Handle and the X-TRACTOR Tip, is substantially equivalent to the following legally marketed predicate devices in consideration of the limited and specific use of the device for stun gun dart removal:
- Sterilogic Waste Systems, Inc. SteriSharp™ Sharps Disposal Containers . (K020664)
Global Pathogen Solutions Inc.
Page 5-1
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- . Dura-Vac Sharps Safe (K955514)
- MedPort, LLC On the Go Sharps Transport and Disposal with Safe Lock™ ● (K070577)
Device Description: The reusable D.A.R.T. Pro Handle and detachable, single-use only X-TRACTOR Tip (including a safety cap) comprise the two components of the device. Each of these components is described generally below.
- D.A.R.T. Pro Handle: A reusable handle component that is uniquely designed . for the secure attachment (and removal post-use) of the X-TRACTOR Tip. The D.A.R.T. Pro Handle allows the user to hold, control and position the assembled product as required for stun gun dart acquisition and removal within the X-TRACTOR Tip. The D.A.R.T. Pro Handle includes a switch at the top of the handle to activate an internal LED light source to illuminate the X-TRACTOR Tip to ease device use in darkened environments. The LED light requires only a standard 9-volt battery, which the user can easily replace as needed.
- X-TRACTOR Tip: A single-use, detachable stun gun dart containment tip . specifically designed to securely house up to two stun gun darts. In use, the X-TRACTOR Tip is placed over the stun gun dart and advanced to lock the dart into a sliding tip collet. The D.A.R.T. Pro Handle is then pulled to remove the dart. The external button on the tip collet is then pressed to slide the tip collet and secure the removed dart within the X-TRACTOR Tip. Following removal of up to two stun gun darts, the safety cap is press-fit over the X-TRACTOR Tip to securely house the darts within the X-TRACTOR Tip. Once placed, the safety cap cannot be removed from the X-TRACTOR Tip. The capped X-TRACTOR Tip is then removed from the D.A.R.T. Pro Handle, placed within a zip-seal bag, and the zip-seal bag appropriately identified for provision to law enforcement personnel.
Device Testing: Performance testing of the D.A.R.T. Pro Kit included the following sharps container tests conducted on the capped X-TRACTOR Tip, which houses the removed stun gun darts.
| Test | Standard | Description | Results |
|---|---|---|---|
| Puncture | Health Devices 22ASTM F04.33.01 | Sharps (needle) penetration force | Pass |
| Leak Resistance | Health Devices 22 | 24 hours filled with water | Pass |
| Vibration | 49 CFR 178.608 | 1 hour repetitive bounce | Pass |
| Free Fall Drop | 49 CFR 178.603 | 5 drops from 3.9 feet | Pass |
| Stacking | 49 CFR 178.606 | 24 hours under 16.6 lbs | Pass |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head with three trailing ribbons, symbolizing care and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Carson Linker President/ Chief Executive Officer Global Pathogen Solutions, Incorporated 9515 N.E.312th Avenue Camas, Washington 98607
SEP - 2 2008
Re: K081821
Trade/Device Name: D.A.R.T. (Stun Gun Dart-Acquiring and Removal Tool) Pro Kit, Including the D.A.R.T. Pro Handle and X-TRACTOR Tip Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: August 20, 2008 Received: August 22, 2008
Dear Mr. Linker:
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 (PMA), 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). For questions regarding postmarket surveillance, please contact CDRIT's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
JHSamuelsteno, mis foell
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 4: INDICATIONS FOR USE
510(k) Number (if known): K08182|
Device Name: D.A.R.T. (stun gun Dart-Acquiring and Removal Tool) Pro Kit, including the D.A.R.T. Pro Handle and X-TRACTOR Tip
Indications for Use: The D.A.R.T. Pro Handle and X-TRACTOR Tip are solely intended for use in the acquisition, removal and storage of darts projected from stun guns and lodged in human tissue and/or clothing. The device is not intended for use as a medical sharps container.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page __ of ___________________________________________________________________________________________________________________________________________________________________
Global Pathogen Solutions Inc.
CONFIDENTIAL
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§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).