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.

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

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Haselmeier Pen, an autoinjector. It states that the device has been demonstrated to perform as intended and is substantially equivalent to legally marketed devices. However, it does not contain specific acceptance criteria, detailed study results, or information regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed performance study against explicit criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of what information can be extracted or inferred:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The implicit criteria are that it performs similarly to predicate devices.	"The Haselmeier Pen has been demonstrated to perform as intended."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document states "The Haselmeier Pen has been demonstrated to perform as intended," implying internal testing, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/not specified. The document does not describe the establishment of ground truth for a test set in the context of expert review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not specified. There is no mention of an adjudication method as no expert review for a test set is described.

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 medical device (autoinjector), not an AI diagnostic tool involving human readers.

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

Not applicable. This is a mechanical device, not an algorithm. The "standalone performance" would relate to the device's mechanical function, which is described as "perform[ing] as intended," but specific test results are not provided.

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

Not applicable/not specified in the sense of clinical ground truth for a diagnostic AI. For a mechanical device, "ground truth" would implicitly be its ability to accurately deliver a dose, be compatible with cartridges/needles, and function reliably. The document states the pen is compatible with ISO standards (ISO 11608-2 and ISO 11608-3) for needles and cartridges, implying these standards serve as the "ground truth" or performance benchmark for compatibility.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.

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

Not applicable.

Summary

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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 syringe21 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

MAR 2 1 2007

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Page 2 of 2

evice Description

K070100

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

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).

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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.

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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

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INDICATIONS FOR USE

510(k) Number (if known):

K070100

Device Name:

Haselmeier Pen

Sponsor Name:

Haselmeier Sàrl

Indications for Use:

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

Regulation Number and Section

§ 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).