(70 days)
Not Found
No
The description details a purely mechanical pen injector with no mention of software, data processing, or any AI/ML related terms.
No
This device is a drug delivery system, not a therapeutic device. It aids in the administration of drugs but does not itself provide therapy.
No
The device is described as a hand-held mechanical device for the subcutaneous, self-administration of FDA-approved drugs and biologics. Its purpose is to deliver medication, not to diagnose a condition.
No
The device description clearly states it is a "hand-held mechanical device" and a "self injection device," indicating it is a physical hardware product, not software.
Based on the provided information, the Haselmeier Pen is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "subcutaneous, self-administration of FDA-approved drugs and biologics." This describes a device used to deliver medication into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a mechanical device for injecting substances, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic procedures.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Haselmeier Pen's function is solely to deliver medication.
N/A
Intended Use / Indications for Use
The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.
Product codes (comma separated list FDA assigned to the subject device)
KZH
Device Description
The Haselmeier Pen is a self injection device for use as a reusable multiple dose delivery system for subcutaneous injections of FDA-approved drugs and biologics. A cartridge is loaded into the barrel of the pen and a needle attached. The user sets the dose required and delivers the dose by pressing down on the top of the dose button. After injection, the needle is removed from the pen and discarded.
The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2 2000 Pen-injectors for medical use - Part 2: Needles - Requirements and test method and 3-ml ISO type A cartridges (supplied separately), which meet ISO 11608-3 2000 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods, with the following dimensions:
Overall cartridge length including aluminum cap: 63.9 mm ± 0.3 mm
Outside Cartridge Diameter: 11.94 mm MAX.
Inner Cartridge Diameter: 9.65 mm ± 0.1 mm measured at open end.
Maximum eccentricity of aluminum cap: 0.33 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Haselmeier Pen has been demonstrated to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Haselmeier Sàrl Haselmeier Pen Hasemiary 510(k) Premarket Notification
Page 1 of 2
Ko 7 0/00
510(k) SUMMARY
General Information
Submitted by:
Contact Person:
Haselmeier Sàrl 5 route de St Cergue CH-1295 Mies Switzerland
Robert J. Kilgore Haselmeier USA 517 Benfield Road Suite 301 Severna Park, MD 21146-2596
Phone: 410 647-7300 410 647-7383 Fax: Email: r.kilgore@haselmeier.com
Date Prepared:
March 5, 2007
Device Name
| Trade Name: | Haselmeier Pen |
|---|---|
| Common Name: | Autoinjector, Pen Injector |
| Classification Name: | Syringe Needle Introducer, Piston syringe |
| 21 CFR 880 6920 21 CFR 880 5860 |
Predicate Device
| Manufacturer | Product Name | 510(k) No |
|---|---|---|
| SHL Medical, USA | DAI-RTM Autoinjector | K060141 |
| Disetronic Medical System | Disetronic Pen | K982966 |
| Eli Lilly and Company | HumaPen and HumaPen Ergo | K982842 |
A
MAR 2 1 2007
1
Page 2 of 2
evice Description
The Haselmeier Pen is a self injection device for use as a reusable multiple dose delivery system for subcutaneous injections of FDA-approved drugs and biologics. A cartridge is loaded into the barrel of the pen and a needle attached. The user sets the dose required and delivers the dose by pressing down on the top of the dose button. After injection, the needle is removed from the pen and discarded.
The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2 2000 Pen-injectors for medical use - Part 2: Needles - Requirements and test method and 3-ml ISO type A cartridges (supplied separately), which meet ISO 11608-3 2000 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods, with the following dimensions:
Overall cartridge length including aluminum cap: Outside Cartridge Diameter: Inner Cartridge Diameter:
Maximum eccentricity of aluminum cap:
63.9 mm ± 0.3 mm 11.94 mm MAX. 9.65 mm ± 0.1 mm measured at open end. 0.33 mm
Intended Use
The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.
Technological Comparison
The Haselmeier Pen has similar indications for use to the DAI-R™ Autoinjector and is similar in design and operating principle to the Disetronic Pen, HumaPen, and HumaPen Ergo.
Testing
The Haselmeier Pen has been demonstrated to perform as intended.
Conclusions
The Haselmeier Pen is substantially equivalent to legally marketed devices (autoinjectors and pen injectors).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert J. Kilgore Director Haselmeier USA 517 Benfield Road, Suite 301 Severna Park, Maryland 21146-2596
MAR 2 1 2007
Re: K070100
Trade/Device Name: Haselmeier Pen Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: March 5, 2007 Received: March 5, 2007
Dear Mr. Kilgore:
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 in ture 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.
3
Page 2 - Mr. Kilgore
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
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
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Haselmeier Pen
Sponsor Name:
Haselmeier Sàrl
Indications for Use:
The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.
Prescription Use (21 CFR 801 Subpart D) Or
Over-The-Counter Use (21 CFR 807 Subpart C)
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard C. Chapman for ADw 3/21/07
70100