AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.

K071517 · A.B.M. Italia S.P.A · MMK · Apr 2, 2008 · General Hospital

Device Facts

• Record ID: K071517
• Device Name: AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
• Applicant: A.B.M. Italia S.P.A
• Product Code: MMK · General Hospital
• Decision Date: Apr 2, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

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 Story

Sharps containers for collection/disposal of needles, scalpels, lancets, and other sharp instruments; used in hospitals, laboratories, and clinics. Containers consist of polypropylene body and lid; available in round (PBS line) or square (CS/Nursy lines) shapes. Operation involves vertical entry of sharps into container; permanent locking mechanism engages upon reaching maximum fill level to prevent re-opening and injury. Healthcare providers dispose of full, locked containers. Benefits include puncture resistance, leak-proof design, and secure containment to prevent accidental sharps injury.

Clinical Evidence

No clinical data. Bench testing only. Mechanical testing included impact resistance (no damage after 1m drop), puncture resistance (average >18 N, min >12.5 N), and leak resistance (leak-proof sides/bottom; Nursy line also leak-proof at top).

Technological Characteristics

Materials: Polypropylene resin with masterbatch colorant (no heavy metals/cadmium). Construction: Injection-molded body and lid. Form factor: Round (PBS) or square (CS/Nursy) containers, 0.6L to 12L capacity. Features: Vertical entry, permanent locking closure system. Single-use.

Indications for Use

Indicated for use by healthcare providers in hospitals, labs, clinics, and veterinary facilities for the safe disposal of sharps, including needles, scalpels, lancets, and other sharp instruments.

Regulatory Classification

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.

Predicate Devices

• Sharps-Tainer (K961878)
• The sharps collection and disposal system (K9451197)

Submission Summary (Full Text)

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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 [phone], Fax [phone]

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. [phone] - Fax [phone] www.apmedical.it - [e-mail]

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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. [phone] - Fax [phone] www.apmedical.it - [e-mail]

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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. [phone] - Fax [phone] www.apmedical.it - [e-mail]

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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 and<br>disposal 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 the<br>lid<br>Nursy: Closure by rotation and<br>pressure 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:<br>Sharps-Tainer | AP MEDICAL<br>PBS | PREDICATE<br>DEVICE:<br>The sharps<br>collection and<br>disposal system | AP MEDICAL<br>CS - NURSY |
|----|----------------------------------------------------------|------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| 1. | Impact<br>Resistance | Pass | No damage after<br>dropping from 1 mt | Pass | No damage after<br>dropping from 1 mt |
| 2. | Puncture<br>Resistance (base,<br>sides, closure,<br>top) | Pass | Average > 18 N,<br>min >12.5 N | Pass | Average > 18 N, min<br>>12.5 N |
| 3. | Leak Resistance<br>(sides and<br>bottom) | Pass | The containers are<br>leak proof on sides<br>and bottom | Pass | The containers are<br>leak proof on sides<br>and bottom<br>Nursy line is leak<br>proof 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. [phone] - Fax [phone] www.apmedical.it - [e-mail]

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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 [phone]. 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 [phone] or [phone] 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:

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

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.