DEPOTONE

K050505 · Imprint Pharmaceuticals Limited · FMI · Apr 5, 2005 · General Hospital

Device Facts

• Record ID: K050505
• Device Name: DEPOTONE
• Applicant: Imprint Pharmaceuticals Limited
• Product Code: FMI · General Hospital
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.

Device Story

DepotOne is a sterile, single-use hypodermic needle consisting of a stainless steel tube with a lancet tip and a side aperture for fluid delivery/removal. The proximal end features a polycarbonate 6% locking Luer connector (hub) attached via epoxy adhesive. The device is designed to mate with a male Luer connector on a piston syringe or intravascular administration set. It is supplied with a polypropylene needle protector. The device is used by healthcare professionals to inject or remove fluids from below the skin surface. It is sterilized using ethylene oxide (ETO). The reduced-diameter tip and side aperture facilitate fluid flow. The device provides a sterile, secure interface for fluid administration or aspiration, benefiting patients by enabling controlled subcutaneous or intravascular access.

Clinical Evidence

Bench testing only. Testing included bend tests (EN ISO 9626), breakage tests, needle/hub bond tests, patency of lumen tests, extractables, acidity/alkalinity tests (EN ISO 7864), fluid flow tests, and penetration force tests. Sterilization validated to SAL 10^-6 per EN 556. Pyrogenicity tested via LAL method. Residual ethylene oxide gas tested per EN ISO 10993-7.

Technological Characteristics

Materials: Stainless steel cannulae, polycarbonate hub, silicone lubricant, epoxy adhesive, polypropylene shield. Dimensions: 23/18G and 27/21G XTW gauges; 3/8" to 1 1/2" lengths. Connectivity: 6% locking Luer connector (ISO 594-2). Sterilization: Ethylene oxide (ETO). Standards: ISO 7864:1993, ISO 594-2, ISO 6009, EN ISO 9626:1995, EN 550, EN 556.

Indications for Use

Indicated for the injection and removal of fluids from below the surface of the skin in humans. Intended for use with a syringe or intravascular administration set.

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

• K-Pack II Needle (K984576)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains a sequence of three triangles arranged horizontally. The triangles are oriented such that their bases are aligned vertically, and their apexes point to the right. The triangles are positioned adjacent to each other, creating a visual effect of progression or directionality from left to right.

# APR 5 2005 Imprint Pharmaceut

Summary of Safety & Effectiveness for 510k Application

- I Imprint Contact Person: Mervyn Little Device Development Director Imprint Pharmaceuticals Ltd. 53 Langton Road East Molesey Surrey KT8 2HX Phone [phone] E-mail: [e-mail]
- Device Name: DepotOne™ 2
- 3 Common Name: Hypodermic Needle
- 4 Classification Name: Hypodermic Single Lumen Needle (880.5570)
- 5 Predicate Device: K-Pack II Needle. Ref K984576
- 6 Product Description: Single use Hypodermic Needle.
- 7 Intended Use: DepotOne is a sterile single use hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans.
- 8 Description: The DepotOne needles comprise of a length of Hypodermic grade stainless steel tube connected to a female connector (hub) that is designed to mate with a male connector of a piston syringe or an intravascular administration set. The other end of the tube is sharpened with a lancet tip in accordance with ISO7864: 1993. The sharpened section of tube is of a reduced diameter. The fluid is injected or removed through a side aperture adjacent to the sharpened tip.
- 9 Substantial Equivalence: The DepotOne™ needles in this 510k submission are substantially equivalent in intended use, principles of operation and materials to the cleared K-Pack Hypodermic Single Lumen Needle that is the subject of K984576. The differences between the devices cited in this section do not raise any new safety issues or new issues relating to effectiveness.

{1}------------------------------------------------

## Design & Materials:

DepotOne and K-Pack II needles are manufactured from stainless steel hypodermic grade tube.

The tip of DepotOne™ is reduced in diameter. An opening is ground into the side of the tube close to the sharpened tip to facilitate the delivery or removal of the fluids. The tip diameter of the K Pack II needle is not reduced, the opening is in the tip. Both needles are sharpened at the tip in accordance with ISO7864.

The proximal end of both needles is securely attached to a 6% Luer connector by means of an epoxy adhesive. The Luer connector is a locking fitting and is in accordance with ISO 594-2 (the K-Pack needle Luer connector does not completely meet the requirements of ISO 594-2). The connector is colour coded in accordance with ISO 6009.The DepotOne connector is manufactured from polycarbonate. The material differs from the material used in the predicate devices and was selected for its superior bond strength when glued. The difference in the materials does not have any impact on the sterilisation. The polycarbonate used in the manufacture of the hub is approved for EO and gamma sterilisation by the manufacturer.

Both needles are supplied fitted with a rigid moulded polypropylene needle tip protector (shield). The colour of this moulding is clear.

Both needles are sterilised using ethylene oxide (ETO).

The difference between DepotOne and the predicate device do not raise any significant issues of safety and effectiveness and do not affect the substantial equivalence.

| Product Code | Needle Gauge | Needle Length | Needle Bevel |
|--------------|--------------|---------------|-----------------|
| D118021 | 23/18G XTW | 3/8" | Standard Lancet |
| D118022 | 23/18G XTW | ½" | Standard Lancet |
| D118023 | 23/18G XTW | 3/4" | Standard Lancet |
| D118024 | 23/18G XTW | 1" | Standard Lancet |
| D118025 | 23/18G XTW | 1 1/4" | Standard Lancet |
| D118026 | 23/18G XTW | 1 1/2" | Standard Lancet |

## Proposed Product:

| Product Code | Needle Gauge | Needle Length | Needle Bevel |
|--------------|--------------|---------------|-----------------|
| D118041 | 27/21G XTW | 3/8" | Standard Lancet |
| D118042 | 27/21G XTW | 1/2" | Standard Lancet |
| D118043 | 27/21G XTW | 3/4" | Standard Lancet |
| D118044 | 27/21G XTW | 1" | Standard Lancet |
| D118045 | 27/21G XTW | 1 ¼" | Standard Lancet |
| D118046 | 27/21G XTW | 1 ½" | Standard Lancet |

{2}------------------------------------------------

## Materials:

| Component | Predicate K984576 | Proposed DepotOne™ |
|-----------------------|-------------------|--------------------|
| Cannulae | Stainless Steel | Stainless Steel |
| Hub (6% Locking Luer) | Polypropylene | Polycarbonate |
| Needle Lubricant | Silicone | Silicone |
| Adhesive | Epoxy | Epoxy |
| Sterilisation Method | ETO | ETO |
| Needle Shield | Polypropylene | Polypropylene |

#### Sterile Hypodermic Needles for Single Use. EN ISO 7864:1993

DepotOne™ conforms to the requirements of ISO 7864:1993 Sterile Hypodermic Needles for Single Use.

#### Tests

DepotOne™M needles have passed the following tests:

Bend tests to EN ISO 9626:1995 Stainless Steel Tubing for the Manufacture of Medical Devices. (see note) Breakage tests to EN ISO 9626:1995 Stainless Steel Tubing for the Manufacture of Medical Devices. Needle/Hub Bond tests to EN ISO 7864:1993 Sterile Hypodermic Needles for Single Use. Patency of Lumen tests to EN ISO 7864:1993 Sterile Hypodermic Needles for Single Use. Extractables tests to EN ISO 7864:1993 Acidity and alkalinity tests to EN ISO7864: 1993

Additional tests: Fluid Flow Tests, Breakage tests for completed needles, Bend tests for complete needles includes the swaged tip, Penetration force tests.

None of the tests raised any issues relating to safety or effectiveness.

### Note:

DepotOne™ XTW needles have passed all the above tests. However it should be noted that ISO9626 (Stainless Steel Tubing for the Manufacture of Medical Devices) does not specify a maximum deflection for 1.2mm (18G) XTW tube or 0.8mm (21G) XTW tube (no data is presented in the standard).

The nearest data available is for 19G XTW and 22G XTW tube. The 1.2mm XTW tube passes the requirements for 1.1mm (19G) XTW tube and the 0.8mm XTW tube passes the requirements for 0.7mm (22G) XTW tube.

{3}------------------------------------------------

\$\psi\$ 45 \$\psi\$ 45 \$\psi\$ (4 of 4)

## Sterilisation

DepotOne™ needles have been subjected to and passed the following tests:

DepotOne needles are EO sterilised by a validated sterilisation method in accordance with the requirements of EN550. The sterilisation of DepotOne™ has been certified to comply with the requirements of EN556 and validated by an independent laboratory to a Sterility Assurance Level (SAL) of 106.

## Bioburden test.

DepotOne needles have been tested for freedom of Pyrogens by means of LAL (limulus amebocyte lysate) test conducted by an independent laboratory in accordance with European Pharmacopoela.

A LAL test is performed on samples from every production batch/lot.

DepotOne needles have been tested for residual gas contents test in accordance with EN ISO10993-7. Limiting viewe 20mg ethylene oxide/24hrs.

## Conclusion

The DepotOne™ needles submitted in this 510k file are substantially equivalent in intended use, design principles, operation, and materials to the cleared K-Pack Single Lumen Needle that is subject to K984576.

The differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle are three curved lines that appear to be stylized representations of the human form. The logo is simple and clean, with a focus on the text and the abstract human figures.

APR 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Imprint Pharmaceuticals Limited C/O Mr. Tamas Borsai Responsible Third Party Official TUV Rheinland of North America, Incorporated 12 Commerce Road Newton, Connecticut 06470

Re: K050505

Trade/Device Name: DepotOne™ Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 17, 2005 Received: March 21, 2005

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your 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 cnactment date of the Medical Device merstate comments, or to devices that have been reclassified in accordance with the provisions of Anchuments, on to devrees and Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drug, and Connenay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls providents or 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 If your device to subject to such additional controls. Existing major regulations affecting (FMA), It may be subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Seas nouncements concerning your device in the Federal Register.

{5}------------------------------------------------

## Page 2 - Mr. Borsi

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 12 a determination that your device complies with other requirements mount that I Dr. Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal time Act's requirements, including, but not limited to: registration 1 ou intist compry wart 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 ce rear 801), equality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form nroduct 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) This letter will are n you be begal finding of substantial equivalence of your device to a premarket notification. - The wice 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), rf you donto specifical of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj obtain 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,

Chia-Lin, Ph.D.

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

{6}------------------------------------------------

## Statement of Intended Use

K050505 510(k) Number DepotOne™ Device Name: DepotOne is a sterile hypodermic single Intended Use lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.

(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)

ાર

Over-The-Counter Use

(Optional Format 1-2-96)

J.M. V.M.

vision Sign-Off) in hion at Anesthasiology, General Hospital, Creenon Control. Dental Devices

: Number: K454545

3.1.1