The OVUS Capless Safety Needle, when used with a standard commercially available syringe, is intended to inject fluids into, or withdraw fluids from, parts of the body, including the applications of hypodermic injection, veinipuncture, and drawing of arterial blood. The needle is retracted after use to prevent accidental needle sticks.

Device Description

The OVUS Capless Safety Needle is a retractable needle system that provides anti-sharps protection. The device is made of the following components: (1) a slotted plastic housing, (2) a needle with a tab on the hub that protrudes from the slot in the housing when installed, (3) a spring that fits over the metal needle shaft, (4) a collar bonded to the proximal end of the housing to prevent the needle from sliding out, (5) a locking pin to prevent reuse (tamper-proof version only), and (6) a dust cover for the distal end of the device. The housing has a slot that allows the tab on the needle hub to slide toward the distal end and into the extended position with the needle fully exposed. At each end of the slot there is a short perpendicular slot that serves to lock the needle/tab in either the fully retracted or fully extended position. When extended, the spring is compressed and would tend to retract the needle unless it were locked in the extended position.

AI/ML Overview

This 510(k) summary describes a medical device, the OVUS Capless Safety Needle, which is a retractable needle system designed to prevent accidental needle sticks. The summary focuses on establishing "substantial equivalence" to predicate devices rather than providing specific acceptance criteria and detailed study results in the manner typically found for AI/software-based devices.

Therefore, for aspects like acceptance criteria, sample sizes, expert qualifications, and detailed performance metrics, the available document does not contain the granular information usually requested for AI device studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds or benchmarks. Instead, it describes a comparative evaluation against predicate devices based on "functionality outcome measures" and "safety" ratings from participants in simulated-use studies. The reported device performance is qualitative and comparative.

Acceptance Criterion (Implicit)	Reported Device Performance (OVUS Capless Safety Needle)
Functionality (vs. Needle-Pro)	- Preferred in all but one of six functionality measures in one study.
	- Preferred in 3/6 functionality measures in another study.
	- Statistical significance obtained for 4/6 and 1/6 measures respectively.
Functionality (vs. VanishPoint)	- Preferred on only 1/6 functionality measures.
	- Differences were very small and none were significant.
Safety (vs. Needle-Pro)	- Rated higher on safety.
	- Equivalence established in both studies in primary analysis.
Safety (vs. VanishPoint)	- Expressed a slight (non-significant) preference for the safety feature.
Substantial Equivalence	- Demonstrated substantial equivalence to predicate devices based on performance data from simulated-use studies.

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

Sample Size: The document does not specify the exact number of participants or the number of simulated uses in the "simulated-use studies." It refers to "participants in the three studies."
Data Provenance: Not specified. Given the context of a US FDA submission, it is highly likely the studies were conducted in the United States, but no explicit country of origin is mentioned. The studies were prospective simulated-use studies.

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

This section is not applicable in the traditional sense of ground truth for an AI/diagnostic device. The "ground truth" here is the user experience and safety perception during simulated use, as rated by the participants themselves. These participants are not described as "experts" creating a definitive ground truth label, but rather as users evaluating the device.

4. Adjudication Method for the Test Set

Not applicable. The study involved participants rating the devices, and the results were likely aggregated and analyzed statistically. There's no mention of an "adjudication method" in the context of resolving discrepancies in expert labeling or diagnoses.

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

The study described is not an MRMC comparative effectiveness study focused on human reader improvement with AI assistance. It is a simulated-use comparison of a new medical device (a safety needle) against predicate devices, focusing on user-reported functionality and safety. This device is not an AI/software as a medical device (SaMD).

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

This is not applicable as the device is a physical medical device (safety needle), not an algorithm or AI. Its performance is intrinsically linked to human interaction during its use.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on user ratings and perceptions of functionality and safety during simulated use. It is not an objective, independently verified ground truth like pathology or outcomes data, but rather subjective feedback from the study participants.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" for an algorithm. The development and testing likely involved engineering and design iterations, but not algorithm training data.

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

Not applicable, as there is no training set mentioned for an algorithm.

Summary

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K013006

510(k) Summary

FEB 0 6 2002

OVUS Capless Safety Needle

Common/Classification Name: Single lumen needle, 21 CFR 880.5570

OVUS Systems, Inc. 5004 Rittenhouse Street Riverdale, MD 20737

Owais Mohammad, Prepared: November 26, 2001 Contact:

LEGALLY MARKETED PREDICATE DEVICES A.

The OVUS Capless Safety Needle, when used with a standard commercially available syringe, is substantially equivalent to the Retractable Technologies Pop-N-Lok Syringe that was cleared for marketing by FDA under K946219 on December 28, 1995. It is also substantially equivalent to the Needle-Pro needle protection device that is manufactured by Concord Portex and cleared for marketing by FDA under K904198 and K911037.

B. DEVICE DESCRIPTION

The housing has a slot that allows the tab on the needle hub to slide toward the distal end and into the extended position with the needle fully exposed. At each end of the slot there is a short perpendicular slot that serves to lock the needle/tab in either the fully retracted or fully extended position. When extended, the spring is compressed and would tend to retract the needle unless it were locked in the extended position.

To use the device, the package is opened and a syringe of the appropriate diameter is inserted into the needle hub. The needle is

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then unlocked and slid into the fully extended position and again locked. With the needle in the fully extended and locked position, the procedure is carried out as usual. Following the procedure, the needle is unlocked and retracted into the housing. When fully retracted, the needle is locked into the retracted position. For the tamper-proof version, the needle is permanently locked in the retracted position by pressing in the tamper-proof pin. The needle is then placed in an antisharps container.

C. INTENDED USE

The OVUS Capless Retractable Safety Needle, when used with a standard commercially available syringe, is intended to inject fluids into, or withdraw fluids from, parts of the body, including the applications of hypodermic injection, veinipuncture, and drawing of arterial blood. The needle is retracted after use to prevent accidental needle sticks.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The OVUS Capless Safety Needle is a medical device, and it has similar, but not identical indications for use statement as the legally marketed predicate devices. In regard to the safety feature, the OVUS Capless Safety Needle has somewhat different technological characteristics as the predicate devices. However, the new characteristics do not raise new safety or effectiveness issues. Accepted scientific methods are available to assess the new For those characteristics, performance data from characteristics. simulated-use studies is provided. The performance data demonstrates that the OVUS Capless Safety Needle is substantially equivalent to the predicate devices.

E. TECHNOLOGICAL CHARACTERISTICS

The OVUS needle is made from the same materials as are the predicate devices -- medical plastics and stainless steel.

The safety feature of the needle uses a different approach from the predicate devices. The Needle-Pro needle employs a protective cap that can be snapped over the needle following use. The VanishPoint needle and syringe uses a retractable needle as its safety feature, but the retraction is automatic once it is triggered, while the OVUS needle is manually operated for extension and retraction. The VanishPoint needle is retracted into the barrel of the syringe following use, while the OVUS needle is retracted into a protective housing, allowing the syringe to operate independently of the needle.

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TESTING r.

Simulated-use studies were carried out to compare the performance of the OVUS needle with the two predicate devices using three different types of needle procedures, hypodermic injection, veinipuncture, and arterial blood draw. The participants in the three studies rated the OVUS Capless Safety Needle very close to the predicate devices on the functionality outcome measures.

In comparison to the Needle-Pro device, the OVUS needle was preferred in all but one of the six functionality measures in one study and in 3/6 in the other, though statistical significance was only obtained for 4/6 and 1/6 In comparison to the much more expensive and respectively. technologically complicated VanishPoint device, the OVUS needle was preferred on only 1/6 functionality measures, though the differences were very small and none were significant.

The participants rated the OVUS needle higher than the Needle-Pro needle on safety. In the primary analysis, equivalence was established in The participants expressed a slight (non-significant) both studies. preference for the safety feature of the OVUS needle compared to the VanishPoint needle.

G. CONCLUSIONS

This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings.

FEB 0 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ovus Systems C/O Dr. T. Whit Athey C.L. McIntosh & Associates 12300 Twinbrook Parkway, Suite 230 Rockville, Maryland 20852

Re: K013006

Trade/Device Name: Ovus Capless Safety Needle Regulation Number: 880.5860 Regulation Name: Single Lumen Hypodermic with Anti-Shapes Feature Regulatory Class: II Product Code: MEG Dated: November 27, 2001 Received: November 27, 2001

Dear Dr. Athey:

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 - Dr. Athey

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

Timothy A. Ulatowski

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

Enclosure

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K013006

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): _________ KO13006

OVUS Capless Safety Needle Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Patricia Cucenta
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices ും Number ___________________________________________________________________________________________________________________________________________________________________ 013000

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).