(17 days)
The Haselmeier Pen 8 is a hand-held mechanical device intended for subcutaneous selfadministration of FDA-approved drugs and biologics. The Haselmeier Pen 8 is designed to be used with 3.0 mL cartridges which are prefilled prior to injection. The Haselmeier Pen 8 is for use in the home environment to aid and support prescribed treatment and therapy.
The Haselmeier Pen 8 is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of medication from single lumen hypodermic needle. The device can be used by health professionals or for selfinjection by the patient.
The pen-injector uses 3.0-mL cartridges of medication and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose (0.08 mL).
The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2:2000 Pen-injectors for medical use PPart 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
The provided text describes a 510(k) Premarket Notification for the Haselmeier Pen 8, a reusable pen-injector. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance acceptance criteria and a detailed study proving those criteria.
Therefore, many of the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not available in the provided document. The document primarily details the device's design, intended use, and its conformance to a recognized standard.
Here's an attempt to answer the questions based only on the provided text, while noting what information is missing:
Acceptance Criteria and Device Performance Study
As this is a 510(k) submission for substantial equivalence based on conformance to an international standard, explicit acceptance criteria in the form of specific performance metrics (e.g., accuracy percentages, sensitivity/specificity, etc.) for a novel AI device are not defined. Instead, the "acceptance criteria" are implied by the requirements of the referenced ISO standard and the demonstration that the device "performs as intended."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to ISO 11608-1:2000 ("Pen-injectors for Medical Use – Part 1 Requirements and Test Methods") | "The Haselmeier Pen 8 conforms to the requirements when the methods specified in the ISO Standard, ISO 11 608-1:2000" |
| Performs as Intended (subcutaneous injection of medication with desired dose dial functionality) | "The Haselmeier Pen 8 has been demonstrated to perform as intended." |
| Compatibility with ISO 11608-2:2000 compliant needles | Device is compatible with commercially available pen needles that comply with ISO 11608-2:2000 |
| Compatibility with ISO 11608-3:2000 compliant 3-mL cartridges | Device is compatible with 3-mL ISO type A cartridges meeting ISO 11608-3:2000 |
2. Sample size used for the test set and the data provenance
- Not provided. The document states that the device "conforms to the requirements when the methods specified in the ISO Standard," implying testing was done according to that standard, but specific sample sizes, data provenance (country of origin, retrospective/prospective), or details of the test set are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This device is a mechanical pen-injector, not an AI/diagnostic device that requires expert-established ground truth for a test set. The validation would involve physical and mechanical testing against the ISO standard.
4. Adjudication method for the test set
- Not applicable/Not provided. This concept is typically relevant for studies involving human interpretation or AI output, where disagreements between experts or AI predictions need resolution. For a mechanical device conforming to an ISO standard, adjudication in this sense is not part of the described testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No, not performed. An MRMC study is relevant for evaluating the impact of AI assistance on human readers (e.g., radiologists interpreting images). This device is a mechanical pen-injector, not an imaging or diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a mechanical pen-injector, not an algorithm or AI system.
7. The type of ground truth used
- Physical and mechanical measurements/engineering specifications. The "ground truth" for this device would be its adherence to the specified dimensions, dose accuracy, durability, and other functional parameters as defined by ISO 11608-1:2000. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.
8. The sample size for the training set
- Not applicable/Not provided. This is a mechanical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm is mentioned or relevant here.
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Special 510(k) Premarket Notification Haselmeier GmbH
CONFIDENTIAL
510(k) Summary
SEP 2 6 2008
Page 1 of 2
510(k) SUMMARY
[as required by section 807.92(c)]
General Information
| Submitted by: | Haselmeier GmbHDufourstr. 32CH-8008 ZurichSwitzerland |
|---|---|
| Contact Person: | Robert J. Kilgore |
| Haselmeier USA517 Benfield RoadSuite 301Severna Park, MD 21146-2596 | |
| Phone: 410 647-7300Fax: 410 647-7383Email: r.kilgore@haselmeier.com | |
| Date Prepared: | September 4, 2008 |
| Device Name |
Trade Name: Haselmeier Pen 8 Common Name: Piston syringe
Predicate Devices
Haselmeier Pen
Haselmeier Sàrl
Device Description
The Haselmeier Pen 8 is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of medication from single lumen hypodermic needle. The device can be used by health professionals or for selfinjection by the patient.
The pen-injector uses 3.0-mL cartridges of medication and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose (0.08 mL).
The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2:2000 Pen-injectors for medical use PPart
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Special 510(k) Premarket Notification Haselmeier GmbH CONFIDENTIAL 510(k) Summary Page 2 of2
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
Intended Use
The Haselmeier Pen 8 is a hand-held mechanical device intended for subcutaneous self administration of FDA-approved drugs and biologics. The Haselmeier Pen 8 is designed to be used with 3.0 mL cartridges which are prefilled prior to injection. The Haselmeier Pen 8 is for use in the home environment to aid and support prescribed treatment and therapy.
Technological Comparison
The Haselmeier Pen 8 has similar indications for use and overall function and performs in a similar manner with respect to the Haselmeier Pen 60.
The technological characteristics of the Haselmeier Pen 8 and its drug cartridge are the same as product currently legally marketed in the USA.
Performance Data
The Haselmeier Pen 8 has been demonstrated to perform as intended. The Haselmeier Pen 8 conforms to the requirements when the methods specified in the ISO Standard, ISO 11 608- 1:2000, "Pen-injectors for Medical Use _ Part 1 Requirements and Test Methods."
Conclusion
Haselmeier concludes based on the information presented that the Haselmeier Pen 8 is substantially equivalent to products currently, legally marketed in the USA.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol. The text is in all caps and is smaller than the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2008
Haselmeier GmbH C/O Mr. Stephen J. Goldner President Regulatory Affairs Associates, Incorporated 30833 Northwestern Highway, Suite 121 Farmington, Michigan 48334-2581
Re: K082616
Trade/Device Name: Haselmeier Pen 8 Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 5, 2008 Received: September 9, 2008
Dear Mr. Goldner:
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. Goldner
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Khamuel's Lindmy focy
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
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Special 510(k) Premarket Notification Haselmeier GmbH
CONFIDENTIAL
Indications for Use
Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Haselmeier Pen 8
Sponsor Name:
Haselmeier GmbH
Indications for Use:
The Haselmeier Pen 8 is a hand-held mechanical device intended for subcutaneous selfadministration of FDA-approved drugs and biologics. The Haselmeier Pen 8 is designed to be used with 3.0 mL cartridges which are prefilled prior to injection. The Haselmeier Pen 8 is for use in the home environment to aid and support prescribed treatment and therapy.
Prescription Use X (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)
Gromm
Division Sign-Off) Jivision of Anesthesiology, General Hospital ויו
i10(k) Number: _ 大482616
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§ 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).