(84 days)
The TactiPen is a self injection device intended for the subcutaneous injection of U-100 insulin from a 3-mL cartridge.
The TactiPen is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of U-100 insulin from a 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 U-100 insulin and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose. 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.
Here's a breakdown of the acceptance criteria and study information for the Haselmeier GmbH TactiPen (K083457), based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Conformance to ISO 11608-1:2000, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods." | The TactiPen conforms to the requirements when tested using the methods specified in ISO 11608-1:2000. |
Study Details:
The 510(k) summary for the TactiPen (K083457) is very concise regarding performance data. It primarily relies on demonstrating conformity to an existing international standard rather than presenting specific numerical performance metrics from a proprietary study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The summary simply says, "The TactiPen has been demonstrated to perform as intended" and "conforms to the requirements when tested using the methods specified in the ISO Standard." ISO 11608-1:2000 itself would specify required sample sizes for various tests.
- Data Provenance: Not explicitly stated, but the testing was conducted by Haselmeier GmbH, a Swiss company (Zurich, Switzerland is listed as the address). It can be inferred that the data is prospective, generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The performance data is based on conformance to an engineering standard (ISO 11608-1:2000) for mechanical and functional aspects of the pen injector, not on expert clinical review or interpretation of data to establish a "ground truth" in a diagnostic sense.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the evaluation is against a technical standard, not a diagnostic or clinical "ground truth" that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not relevant for a medical device like a pen injector. MRMC studies are typically used to evaluate the effectiveness of diagnostic aids or tools that assist human readers (e.g., radiologists interpreting images). The TactiPen is a drug delivery device, not a diagnostic or interpretive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes (in essence). The "performance data" provided is for the device itself, functioning independently. There isn't an "algorithm" in the AI sense, but the device's mechanical performance is evaluated without human intervention determining its 'output.' The evaluation is on the device's ability to precisely dial and deliver doses according to specifications.
7. Type of Ground Truth Used
- Technical Standard Compliance: The "ground truth" is defined by the technical requirements and test methods outlined in ISO 11608-1:2000. The device's performance is compared directly against these established engineering and functional benchmarks.
8. Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI algorithms, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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510(k) Premarket Notification Haselmcier GmbH TactiPen
K083457
510(k) Summary
Page 1 of 2
510(k) SUMMARY
[as required by section 807.92(c)]
FEB 1 3 7009
General Information
Submitted by:
Contact Person:
Haselmeier GmbH Dufourstr. 32 CH-8008 Zurich Switzerland
Robert J. Kilgore
Haselmeier USA 517 Benfield Road Suite 301 Severna Park, MD 21146-2596
Phone: 410 647-7300 Fax: --410 647-7383 Email: r.kilgore@haselmeier.com
Date Prepared:
October 2, 2008
Device Name
Trade Name: Common Name: Classification Number: Product Code:
TactiPen Piston syringe 880.5860 FMF
Predicate Devices
| Haselmeier Pen | K070100 | Haselmeier GmbH |
|---|---|---|
| Disetronic Pen | K982966 | Disetronic Medical System |
| HumaPen and HumaPen Ergo | K982842 | Eli Lilly and Company |
Device Description
The TactiPen is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of U-100 insulin from a single lumen hypodermic needle. The device can be used by health professionals or for selfinjection by the patient.
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510(k) Summary
The pen-injector uses 3.0-mL cartridges of U-100 insulin and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose.
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.
Intended Use
The TactiPen is a self injection device intended to deliver a subcutaneous injection of U-100 insulin from a 3-mL cartridge.
Technological Comparison
The TactiPen has similar indications for use and overall function and performs in a similar manner with respect to the Haselmeier Pen, Disetronic Pen, HumaPen, and HumaPen Ergo.
The technological characteristics of the TactiPen and its drug cartridge are the same as product currently legally marketed in the USA.
Performance Data
The TactiPen has been demonstrated to perform as intended.
The TactiPen conforms to the requirements when tested using the methods specified in the ISO Standard, ISO 11608-1:2000, "Pen-injectors for Medical Use - Part 1 Requirements and Test Methods."
Conclusion
Haselmeier concludes based on the information presented that the TactiPen is substantially equivalent to products currently, legally marketed in the USA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2009
Haselmeier GmbH C/o Mr. Stephen J. Goldner, JD, RAC President Regulatory Affairs Associates 30833 Northwestern Highway, Suite 121 Farmington Hill, Michigan 48334-2581
Re: K083457
Trade/Device Name: TactiPen Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 20, 2008 Received: November 21, 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,
Anthony, D., Addison for
Ginette Y. Michaud, M.D. Acting 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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510(k) Premarket Notification Haselmeier GmbH TactiPen
Indications for Use
Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Sponsor Name:
Indications for Use:
TactiPen
・・
Haselmeier GmbH
The TactiPen is a self injection device intended for the subcutaneous injection of U-100 insulin from a 3-mL cartridge.
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) (Division Sign-Off) (Division Sign-Stil)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K683457
§ 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).