AP Medical sharps containers are intended for use by healthcare providers such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities for safe disposal of sharps such as Needles, Scalpels, Lancets and other Sharp Instruments.

Three different lines are offered to our customers and end users: PBS line - disposable round containers with access inlets on the lid, for sharps disposal CS line - disposable square containers with rotating lid for sharps disposal NURSY line - disposable square containers with hermetic permanent closure for sharps disposal

Device Description

Our sharps containers are made of Polypropylene resin and coloured using Masterbatch which contains no heavy metals or cadmium. These materials allow us to produce a very safe, high quality puncture resistant container. Each container is comprised of a Body (either square or round) and a lid. The lids are a very safe and secure fit. All containers are vertical entry. All containers have the maximum filling level line as well as required labelling in accordance with current legislation. These containers are equipped with a permanent closure system, that is the final method of closure. Once the container is closed permanently it is locked closed. It can not manually re-open. This is a very safe method of preventing injury. Once the container is full it is locked and then disposed of. It is safe for anyone coming into contact with the container.

AI/ML Overview

The provided text is a 510(k) premarket notification for AP medical sharps containers. It details a comparison to predicate devices and presents results from non-clinical mechanical tests to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study as requested:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit from Predicate Performance)	Reported Device Performance (AP MEDICAL)
Impact Resistance: Pass (no damage after dropping from 1 meter)	No damage after dropping from 1 meter
Puncture Resistance (base, sides, closure, top): Pass (average > 18 N, min > 12.5 N)	Average > 18 N, min > 12.5 N
Leak Resistance (sides and bottom): Pass (leak proof on sides and bottom)	Leak proof on sides and bottom (Nursy line is also leak proof on top)

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for each mechanical test. It states "The summary data derived from mechanical tests are as follows," implying tests were conducted. The data provenance is from AP Medical Italia S.p.A., presumably at their manufacturing facility in Roncadelle di Ormelle, ITALY. The study appears to be prospective as it involves new testing of their products against established criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study involves mechanical performance testing of physical devices against objective, quantitative criteria (e.g., force in Newtons for puncture resistance, visual inspection for impact/leakage). It does not involve human interpretation or expert-established ground truth in the way a diagnostic AI study would.

4. Adjudication method for the test set

Not applicable. See point 3.

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 is a 510(k) submission for physical medical devices (sharps containers), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm or software. The performance demonstrated is for the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these tests is based on objective, verifiable mechanical properties and performance benchmarks established by the predicate devices and possibly relevant industry standards for sharps containers (though specific standards are not cited in this excerpt, they are implied by the performance criteria). For example, puncture resistance is measured in Newtons, and impact resistance is determined by whether damage occurs after a specific drop height.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for AP medical. The letters "AP" are in large, bold, black font. The word "medical" is in a smaller, italicized, black font and is located to the right of the letters "AP". The logo is simple and professional.

K071517

APR - 2 2008

510 (k) SUMMARY 5.

(as required by 807 92 (c))

807.92 (a)(1)

Submitted by:

A.b.m. Italia S.p.A., Via Ing. G. Taliercio, 1, 31024 Roncadelle di Ormelle (TV), ITALIA Franco Grava (product manager) Phone +39 0422 745 951, Fax +39 0422 745 999

FEBRUARY, 28th 2008

807.92 (a)(2)

Trade name:

PBS 0,6 It. �
PBS 0,6 It. with narrow base ●
PBS 0,8 It. .
PBS 1,5 It. .
PBS 2 It. .
PBS 5 It. .
. PBS 7 It.
PBS 12 It. .
CS 2 It. .
. CS 3 It.
CS 4 It. .
CS 5 It. Low .
CS 5 It. High .
. CS 6 It.
Nursy 3 It. .
Nursy 5 It. .
Nursy 10 lt. ●

Common name: Sharps container

Classification name: Sharps container 80 MMK 880.5570

medical Divisione Medicale di a.b.m. Italia S.p.A., via Ing. G. Taliercio, 1 l - 31024 Roncadelle di Ormelle (TV) - Tel. +39 0422 745900 - Fax +39 0422 745999 www.apmedical.it - info@apmedical.it

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Image /page/1/Picture/0 description: The image shows the logo for AP medical. The letters "AP" are in a bold, sans-serif font, with the "P" slightly smaller and raised compared to the "A". To the right of "AP", the word "medical" is written in a smaller, italicized, sans-serif font. The entire logo is in black against a white background.

807.92 (a)(3)

Equivalent device being legally marketed: For PBS Line: Trade name: Sharps-Tainer Manufactured by: WINFIELD INDUSTRIES 510K approval Number: K961878

For CS and Nursy Line:

Trade name:

The sharps collection and disposal svstem Manufactured by: DEVON INDUSTRIES, INC. 510K approval Number: K9451197

807.92 (a)(4)

Description:

Our sharps containers are made of Polypropylene resin and coloured using Masterbatch which contains no heavy metals or cadmium.

These materials allow us to produce a very safe, high quality puncture resistant container.

Each container is comprised of a Body (either square or round) and a lid. The lids are a very safe and secure fit.

All containers are vertical entry.

All containers have the maximum filling level line as well as required labelling in accordance with current legislation.

CONTAINER	SIZE	SHAPE	FEATURES
(code)	(LT)
PBS 0.6	0.6	ROUND	Closing by pressing the small lid
PBS 0.6 S (with narrow base)	0.6	ROUND	Closing by pressing the small lid
PBS 0.8	0.8	ROUND	Closing by pressing the small lid
PBS 1.5	1.5	ROUND	Closing by pressing the small lid
PBS 2	2	ROUND	Closing by pressing the small lid
PBS 5	5	ROUND	Closing by pressing the small lid
PBS 7	7	ROUND	Closing by pressing the small lid
PBS 12	12	ROUND	Closing by pressing the small lid
CS 2	2	SQUARE	Closing by turning the round part
CS 3	3	SQUARE	Closing by turning the round part
CS 4	4	SQUARE	Closing by turning the round part
CS 5 H	5	SQUARE	Closing by turning the round part
CS 5 L	5	SQUARE	Closing by turning the round part
CS 6 H	6	SQUARE	Closing by turning the round part
NURSY 3	3	SQUARE	Closing by inserting the round lid
NURSY 5	5	SQUARE	Closing by inserting the round lid
NURSY 10	10	SQUARE	Closing by inserting the round lid

TÜV
SIMCERT APmedical

Medicale di a.b.m. Italia S.p.A., via Ing. G. Taliercio, 1 i - 31024 Roncadelle di Ormelle (TV) - Tel. +39 0422 745900 - Fax +39 0422 745999 www.apmedical.it - info@apmedical.it

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Image /page/2/Picture/0 description: The image shows the logo for "AP medical". The letters "AP" are in a bold, sans-serif font and are much larger than the word "medical", which is in a smaller, italicized, sans-serif font. The logo is simple and modern, with a focus on the initials "AP".

These containers are equipped with a permanent closure system, that is the final method of closure. Once the container is closed permanently it is locked closed. It can not manually re-open. This is a very safe method of preventing injury.

Once the container is full it is locked and then disposed of. It is safe for anyone coming into contact with the container.

807.92 (a)(5)

Intended use:

These containers are intended for use by healthcare providers such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities. The containers are designed and used for the safe collection and disposal of sharps such as needles, lancets and other sharp instruments.

They were designed in collaboration with the people from infectious control from different countries in order to satisfy in the best way the hospital's needs as well as the highest security standards.

Furthermore, three different lines offers to our customers and end users to choose the lid closure and design which they prefer:

PBS line - round shape container with a very simple definitive closure

CS line - square shape container with turning lid for definitive closure

Nursy line - square shape container with a high shock resistance

All our containers once full must be disposed.

807.92 (a)(6)

All containers of PBS Line are substantially equivalent to Sharps-Tainer container as follows: Comparison table

	PBS Line	Sharps-Tainer
Target population	Healthcare professional	Healthcare professional
Indication for use	Healthcare sharps	Healthcare sharps
Where used	Healthcare facilities/labs	Healthcare facilities/labs
Performance	Single use	Single use
Construction	Injection moulding	Injection moulding
Materials	Polypropylene	Polypropylene
Lid	Closure by pressing the lid	Closure by pressing the lid
Opening	Rounded opening	Squared opening
Needle elimination	By vertical dropping	By vertical dropping

All containers of CS and Nursy Line are substantially equivalent to The sharps collection and disposal system container as follows:

TÜV

SINSERT APmedical

Medicale di a.b.m. Italia S.p.A., via Ing. G. Taliercio, 1 1 - 31024 Roncadelle di Ormelle (TV) - Tel. +39 0422 745900 - Fax +39 0422 745999 www.apmedical.it - info@apmedical.it

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Image /page/3/Picture/0 description: The image shows the logo for AP medical. The letters "AP" are in large, bold, black font. To the right of the letters "AP" is the word "medical" in a smaller, italicized, black font. The logo is simple and professional.

Comparison table

	CS and Nursy Line	The sharps collection anddisposal system
Target population	Healthcare professional	Healthcare professional
Indication for use	Healthcare sharps	Healthcare sharps
Where used	Healthcare facilities/labs	Healthcare facilities/labs
Performance	Single use	Single use
Construction	Injection moulding	Injection moulding
Materials	Polypropylene	Polypropylene
Lid	CS: Closure by rotation of thelidNursy: Closure by rotation andpressure of lid	Closure by rotation of the lid
Opening	Rounded opening	Rounded opening
Needle elimination	By vertical dropping	By vertical dropping

807.92 (b)(1-2-3)

Clinical tests: not applicable.

Non clinical tests: The summary data derived from mechanical tests are as follows:

		PREDICATE DEVICE:Sharps-Tainer	AP MEDICALPBS	PREDICATEDEVICE:The sharpscollection anddisposal system	AP MEDICALCS - NURSY
1.	ImpactResistance	Pass	No damage afterdropping from 1 mt	Pass	No damage afterdropping from 1 mt
2.	PunctureResistance (base,sides, closure,top)	Pass	Average > 18 N,min >12.5 N	Pass	Average > 18 N, min>12.5 N
3.	Leak Resistance(sides andbottom)	Pass	The containers areleak proof on sidesand bottom	Pass	The containers areleak proof on sidesand bottomNursy line is leakproof also on the top

Conclusions:

The containers, as tested, satisfy the criteria as the predicate devices, and are capable of preventing the loss or dispersal of the contents for conditions normal to transport.

Image /page/3/Picture/9 description: The image shows three logos. The first logo is a circular seal with the letters "TUV" inside a triangle. The second logo is "SINCERT" with some text above it. The third logo is "AP medical" with the "AP" in a larger font.

Divisione Medicate di a.b.m. Italia S.p.A., via Ing. G. Taliercio, 1 1 - 31024 Roncadelle di Ormelle (TV) - Tel. +39 0422 745900 - Fax +39 0422 745999 www.apmedical.it - info@apmedical.it

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2008

Mr. Franco Grava Product Manager A.B.M. Italia S.P.A Via Lng. G. Taliercio, 1 Roncadelle Di Ormelle, Italy 31024

Re: K071517

Trade/Device Name: AP medical sharps containers 0.6 – 12 Lt. (PBS 0.6 lt., PBS 0.6 lt. with narrow base, PBS 0.8 lt., PBS 1.5 lt., PBS 2 lt., PBS 5 It., PBS 7 1t., PBS 12 lt., CS 2 lt., CS 3 lt., CS 4 lt., CS 5 lt. Low, CS 5 lt. High, CS 6 lt., Nursy 3 lt., Nursy 5 and Nursy 10 lt.) Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: February 28, 2008 Received: March 5, 2008

Dear Mr. Grava:

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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Page 2 - Mr. Grava

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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.html.

Sincerely yours.

Carl

Chiu Lin. Ph.D. 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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INDICATION FOR USE

510 (K) Number: K071517

Device name: AP medical sharps containers 0,6 - 12 Lt: (PBS 0,6 lt., PBS 0,6 lt. with narrow base, PBS 0,8 lt., PBS 1,5 lt., PBS 2 lt., PBS 5 lt., PBS 7 It., PBS 12 It., CS 2 It., CS 3 It., CS 4 It., CS 5 It. Low, CS 5 It. High, CS 6 It., Nursy 3 lt., Nursy 5 , Nursy 10 lt.)

A.b.m. Italia S.p.A., Via Ing. G. Taliercio, 1, 31024 Roncadelle di Applicant: Ormelle (TV), ITALY

Indications for Use:

Prescription Use (21 CFR 801. Subpart D) and/or Over-the-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device

Shelly M. Murphy, KB

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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402151

510(k) Number.

Regulation Number and Section

§ 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).