PERSONAL INJECTOR

K033696 · Union Medico Aps · KZH · Feb 16, 2005 · General Hospital

Device Facts

• Record ID: K033696
• Device Name: PERSONAL INJECTOR
• Applicant: Union Medico Aps
• Product Code: KZH · General Hospital
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Device is intended to allow patients or carers to self-administer inject able FDA approved drugs or biologics with a safe, simple and easy injection system. Personal Injector is intended to be used in any setting including the home. Personal Injector is intended for use by patients to self-administer or by care-givers for injection of FDA approved drugs or biologics. Personal Injector is intended to introduce the needle below the skin surface. Personal Injector is designed to accommodate two different and replaceable syringeholders. Personal Injector is intended for the use with FDA approved fixed or non-fixed needle syringes supplied with specific injection reqimens. Personal Injector is intended to be used in any setting including the home.

Device Story

Personal Injector is a spring-loaded mechanical syringe needle introducer; designed for home or clinical use by patients or caregivers. Unlike traditional auto-injectors that perform needle insertion and drug delivery in one motion, this device uses a spring-loaded mechanism solely to insert the needle to a pre-determined depth (subcutaneous or intramuscular). After insertion, the user manually controls the plunger to inject the drug, allowing for visual inspection of the site and air bubbles. Accommodates various FDA-approved syringes with fixed or non-fixed needles via replaceable syringe-holders. Benefits include reduced injection pain, bruising, and swelling; provides users with greater control over injection speed and comfort.

Clinical Evidence

A focus group study was conducted in 2001 at Rigshospitalet, Denmark, involving patients using the injector for multiple sclerosis treatment. Results were reported as positive, with high satisfaction from both patients and healthcare professionals.

Technological Characteristics

Mechanical spring-loaded syringe needle introducer. Features replaceable syringe-holders to accommodate various FDA-approved fixed or non-fixed needle syringes. Designed for manual drug delivery following automated needle insertion. No electronic components, software, or energy source other than mechanical spring tension.

Indications for Use

Indicated for patients or caregivers to self-administer FDA-approved injectable drugs or biologics. Suitable for subcutaneous or intramuscular needle introduction. Applicable for various treatment regimens including multiple sclerosis, cancer, growth hormone therapy, erectile dysfunction, and medications like heparin, adrenaline, insulin, and apomorphine.

Regulatory Classification

Identification

A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Predicate Devices

• Autoject 2 (K993385)
• Autoject 2 (K013362)

Submission Summary (Full Text)

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### FEB 1 6 2005

## 510(K) SUMMARY

: 上一篇:

510(k) Number: KO33696 . Product:

| Submitter's Name and Address: | Union Medico<br>Emdrupvej 22<br>2100 Copenhagen<br>Denmark | |
|-------------------------------|----------------------------------------------------------------------------|--|
| Contact Persons: | Michael Perthu<br>Jesper Hulbaek<br>Tel: [phone]<br>Fax: [phone] | |
| Injector: | Personal Injector™ | |
| Class: | Class II | |
| Classification Name: | Syringe Needle Introducers | |
| Classification Panel: | General Hospital, Panel 80<br>Regulation Number 21 C.F.R § 880.6920 | |
| Predicate Device: | Autoject 2 (K993385)<br>Autoject 2 (K013362) | |
| Manufacturing Facilities: | GPV Teknik A/S<br>Smedeland 22, Albertslund<br>2600 Glostrup<br>Denmark | |

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# 15433696 P.Z. 22

#### Device Description

Personal Injector is designed for the user - by a user, and here for a lot of emphasis has been put on functionality and injection comfort, appearance, surface, materials, weight, balance, and sound. Personal Injector is an injection system allowing the user to have maximum control and comfort while injecting.

Personal Injector differs from commonly known Auto-injector. Until today, marketed Autoinjectors are only for subcutaneous injections, and introduce both the needle and the drug in one motion. The injections are associated with discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site. Personal Injector has a spring-loaded mechanism that only serves to introduce the needle to a pre-determined depth, either subcutaneous or intramuscular. Hereafter the patient can check for air bobbles and vein penetration, and perform a safe traditional manual injection of the drug, by slowly and steady pushing the plunger down. Personal Injector minimises pain and support the patient perform the manual drug introduction, avoiding almost all discomfort.

Personal Injector two unique Syringe-Holders is designed to accommodate FDA approved syringes with fixed and non-fixed needles. Personal Injector is suitable for many injection regimes, including multiple sclerosis patients treatment with interferon beta, cancer treatment, children receiving growth hormone treatment, men injecting local vasodilators to treat erectile dysfunction, and injections of heparin, adrenaline, insulin, apomorphine, and many others medications.

#### Intended Use

The Device is intended to allow patients or carers to self-administer inject able FDA approved drugs or biologics with a safe, simple and easy injection system. Personal Injector is intended to be used in any setting including the home.

#### Operational

Personal Injector is designed to accommodate two different and replaceable syringe-holders. The injector is here for designed to use multiple FDA approved fixed or non-fixed needle syringes. Additionally, Personal Injector is intended for Prescription Use and Over-The-Counter Use.

#### Focus Group Study

Personal Injector has been tested at a focus group study in 2001 at Rigshospitalet, the largest MS hospital in Denmark, amongst patients using the Injector. The results were outstanding, and Personal Injector has received wide praise from Patients and Healthcare Professionals alike.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping lines or stripes, with a wavy line at the bottom. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2005

Mr. Michael Perthu Managing Director, CEO Union Medico APS Emdrupvej 22 2100 Copenhagen DENMARK

Re: K033696

Trade/Device Name: Personal Injector Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: January 11, 2005 Received: January 13, 2005

Dear Mr. Perthu:

We have reviewed your Section 510(k) premarket notification of intent to market the device reformed above and have determined the device is substantially cquivalent (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 Lederal Register.

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Page 2 - Mr. Perthu

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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,

Sujata Medicine Omd.

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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### Indications for Use

510(k) Number (if known): K033696

Device Name:

Personal Injector

Indications For Use:

Personal Injector is intended for use by patients to self-administer or by care-givers for injection of FDA approved drugs or biologics. Personal Injector is intended to introduce the needle below the skin surface.

Personal Injector is designed to accommodate two different and replaceable syringeholders. Personal Injector is intended for the use with FDA approved fixed or non-fixed needle syringes supplied with specific injection reqimens.

Personal Injector is intended to be used in any setting including the home.

| Prescription Use | ✓ |
|------------------|---|
| | |

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chris Vance

Cirison (Sign-Off) Inision of Anesthesiology, General Hospital, Infoction Control, Dental Devices

510(K) Number: K933696

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