(118 days)
The Sure-Lok™ secondary needle kit contains a needle w/Sure-Lok™ adapter, sheath, and base stand that is intended for use with standard luer-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-Lok™ adapter engages with the sheath, preventing needle exposure.
The device description of the Sure-Lok™ secondary needle kit is as follows.
- Hypodermic single lumen needle, 20G 25G, 5/8" to 1½" length. u
- Adapter attached to needle with 6% (luer) taper for syringe barrel . attachment.
- Needle Sheath that seals the needle tip and locks with the adapter to I prevent needle exposure.
- . Base Stand that holds the sheath in an upright position during engagement of the needle and sheath.
- Individually packaged and sterilized. l
This submission (K021315) for the Sure-Lok™ secondary needle kit is a 510(k) Pre-Market Notification, indicating it's a submission for substantial equivalence to a predicate device. As such, the document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing acceptance criteria and proving the device meets them through a specific study in the same way a novel device might.
The provided text, therefore, does not contain detailed information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Specific ground truth types for performance studies.
- Training set sample size or ground truth establishment for a training set.
Instead, the submission demonstrates substantial equivalence by comparing the Sure-Lok™ device to two predicate devices (NeedleTrap™ [K950098] and Point-Lok™ [K946289]) across various characteristics.
Here's a summary of what is provided regarding the device's characteristics and its comparison to predicate devices, which implicitly serves as the "proof" of meeting the standards set by already approved devices:
1. Acceptance Criteria and Reported Device Performance (Implied by Substantial Equivalence):
The "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The Sure-Lok™ device is deemed acceptable because it shares the same intended use, technique, safety features, and material properties as the legally marketed predicate devices.
| Characteristic | Predicate Devices (NeedleTrap™ and Point-Lok™ standards) | Sure-Lok™ (Reported Device Performance via Equivalence) |
|---|---|---|
| Intended Use | To protect against accidental needle sticks after needle has been inserted into the device. | Same |
| Technique | Needle is inserted into device with one-hand. | Same |
| Needle Point | After insertion into device, needle tip is sealed to prevent sample contamination and blood spattering. | Same |
| Needle Encapsulation | After insertion into device, the needle is locked into the device and cannot be removed. | Same |
| Base Configuration | Device has a flat base that sits on a flat surface. | Same |
| Color | The device is colored orange / red. | Same |
| Needle Specifications | Can accept needle gage size 12 through 30, 5/8" to 1½" in length, luer slip and luer lock (Point-Lok™).Can accept needle gage size 20 through 25, 1" in length, luer slip and luer lock (NeedleTrap™) | Same (needle gage size 20 to25, 5/8" to 1½" inlength, luer slip and luerlock) |
| Training | No training is required to use the device. | Same |
| Puncture Resistant | Plastics used to encapsulate needles are puncture resistant.Polystyrene (NeedleTrap™), Rubber Modified Polystyrene (Point-Lok™). | Same(Acrylic) |
| Point of Use | Device does not interfere with syringe/needle during sampling.The device encapsulates the needle after it has been used. | Same |
2. Sample size used for the test set and the data provenance: Not applicable. This submission relies on demonstrating substantial equivalence to already approved predicate devices based on design and material comparisons, not a new performance study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a mechanical needle safety device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of a new performance study. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, against which the Sure-Lok™ device is compared. Its compliance with the general controls and regulations for hypodermic single lumen needles, as affirmed by the FDA, serves as validation.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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K0213/5
AUG 2 1 2002
Attachment 6
510(k) Summary
| Device Trade Name | Classification Name | |
|---|---|---|
| Sure-Lok™ | Hypodermic Single Lumen Needle | |
| Contact and | Anthony P. Martino | |
| Address | V.P. Quality and Regulatory Affairs | |
| Vital Signs, Inc.20 Campus Road | ||
| Totowa, NJ 07512 | ||
| (973) 790-1330 phone | ||
| (973) 790-4150 fax | ||
| Food, Drug and Cosmetic Act for this device. | ||
| Point-Lok TM [510(k) K946289]. | The predicate devices are the NeedleTrap™ [510(k) K950098] and the | |
| Predicate DeviceInformation | ||
| Intended Use | The Sure-Lok™ secondary needle kit contains a needle w/Sure-Lok™ |
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Attachment 6
510(k) Summary
Device Description
The device description of the Sure-Lok™ secondary needle kit is as follows.
- Hypodermic single lumen needle, 20G 25G, 5/8" to 1½" length. u
- Adapter attached to needle with 6% (luer) taper for syringe barrel . attachment.
- Needle Sheath that seals the needle tip and locks with the adapter to I prevent needle exposure.
- . Base Stand that holds the sheath in an upright position during engagement of the needle and sheath.
- Individually packaged and sterilized. l
| Substantial | The Sure-Lok™ device has the following similarities with the predicate | ||||
|---|---|---|---|---|---|
| Equivalence | devices: |
| Characteristic | Predicate Devices: Needle Trap and Point-Lok | Sure-Lok |
|---|---|---|
| Intended Use | To protect against accidental needle sticks after needle has been inserted into the device. | Same |
| Technique | Needle is inserted into device with one-hand. | Same |
| Needle Point | After insertion into device, needle tip is sealed to prevent sample contamination and blood spattering. | Same |
| Needle Encapsulation | After insertion into device, the needle is locked into the device and cannot be removed. | Same |
| Base Configuration | Device has a flat base that sits on a flat surface. | Same |
| Color | The device is colored orange / red. | Same |
| Needle Specifications | Can accept needle gage size 12 through 30, 5/8" to 1½" in length, luer slip and luer lock (Point-Lok).Can accept needle gage size 20 through 25, 1" in length, luer slip and luer lock (NeedleTrap) | Same(needle gage size 20 to25, 5/8" to 1½" inlength, luer slip and luerlock) |
| Training | No training is required to use the device. | Same |
| Puncture Resistant | Plastics used to encapsulate needles are puncture resistant.Polystyrene (NeedleTrap), Rubber Modified Polystyrene (Point-Lok). | Same(Acrylic) |
| Point of Use | Device does not interfere with syringe/needle during sampling.The device encapsulates the needle after it has been used. | Same |
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Attachment 6
510(k) Summary
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Section 807, and based on the information provided in this Premarket Notification, Vital Signs, Inc. concludes that the Sure-LokTM device is safe, effective and substantially equivalent to the predicate devices as described herein.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2002
Vital Signs. Incorporated C/O Mr. Thomas W. Dielmann Marquest Medical Products, Incorporated 11039 East Lansing Circle Englewood, Colorado 80112
Re: K021315
Trade/Device Name: Sure-Lok™ Secondary Needle Kit Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 27, 2002 Received: June 28, 2002
Dear Mr. Dielmann:
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.
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.
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Page 2 – Mr. Dielmann
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
$\mathbb{R}$
Timothy A. Ulatowski 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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س
Indications for Use Statement
| 510(k) Number | K021315 |
|---|---|
| Device Name | Sure-Lok™ secondary needle kit |
| Indications for Use | The Sure-Lok™ secondary needle kit contains a needle w/Sure-Lok™ adapter, sheath, and base stand that is intended for use with standard luer-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-Lok™ adapter engages with the sheath, preventing needle exposure. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﺎ (per 21 CFR 801.109)
or
Over-the-counter use
Patricia Cussenitz
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K021313
§ 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).