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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Personal Injector device. It describes the device, its intended use, and provides contact information. However, it does not contain the results of a formal study with acceptance criteria and specific performance metrics in the way a clinical trial or a validation study for a diagnostic device would.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Study Information for Personal Injector

The provided 510(k) summary (K033696) for the Personal Injector device does not include a formal study with quantitative acceptance criteria and reported device performance metrics that are typically found in validation studies for medical devices, particularly those involving diagnostic accuracy or functional performance against specific benchmarks.

The document primarily focuses on demonstrating substantial equivalence to a predicate device and describing the design and intended use of the Personal Injector. It mentions a "Focus Group Study" but provides very limited details about its methodology or quantitative results in relation to pre-defined acceptance criteria.

Here's an attempt to answer the requested points based on the available information, noting significant gaps:

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

Based on the provided document, no quantitative acceptance criteria or specific device performance metrics (e.g., success rate of needle insertion, pain reduction scores, etc.) are explicitly stated in a table format or otherwise reported as part of a formal study aimed at proving the device meets said criteria.

The closest statement regarding performance is: "The results were outstanding, and Personal Injector has received wide praise from Patients and Healthcare Professionals alike." This is a qualitative, subjective statement and not a measurable performance metric against defined acceptance criteria.

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: Not specified for the "Focus Group Study."
Data Provenance: The "Focus Group Study" was conducted in Denmark ("Rigshospitalet, the largest MS hospital in Denmark"). It appears to be a prospective study in the sense that patients "using the Injector" participated.

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)

The document mentions "Healthcare Professionals" providing "wide praise," but it does not specify the number or qualifications of these experts involved in establishing any formal "ground truth" or evaluative criteria for the focus group study. The focus group participants were primarily patients.

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

None specified. The nature of the "Focus Group Study" suggests qualitative feedback collection rather than a formal adjudication process involving multiple expert reviewers.

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

No MRMC study was performed or mentioned. This type of study is typically relevant for diagnostic imaging devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Personal Injector is a physical injection device, not a diagnostic tool.

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

Not applicable. The Personal Injector is a physical medical device designed for human interaction (patient or caregiver) during injection. It does not involve an algorithm or a standalone 'AI-only' performance component in the context of typical standalone device evaluations for AI-powered systems. Its function is to facilitate manual drug injection.

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

The "ground truth" equivalent in the "Focus Group Study" would be patient and healthcare professional feedback/satisfaction regarding "functionality and injection comfort, appearance, surface, materials, weight, balance, and sound," and minimizing "discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site." This is primarily subjective experience and qualitative feedback, not an objective "ground truth" like pathology for a diagnostic device.

8. The sample size for the training set

Not applicable. The Personal Injector is a mechanical device, not an AI/ML model that requires a "training set" in the computational sense. The document describes a "Focus Group Study" which is an evaluation, not a training phase.

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

Not applicable. As a mechanical device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning.

Summary of Limitations:
The provided 510(k) summary is for a device seeking substantial equivalence based on its physical and functional characteristics compared to predicate devices, rather than an AI-driven or diagnostic device requiring extensive performance studies with quantitative acceptance criteria, large training/test sets, or MRMC studies. The "Focus Group Study" mentioned is qualitative and lacks the detailed methodological reporting (sample size, expert qualifications, clear metrics) common in formal clinical validation studies that establish performance against pre-defined acceptance criteria.

Summary

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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 MedicoEmdrupvej 222100 CopenhagenDenmark
Contact Persons:	Michael PerthuJesper HulbaekTel: +45 70266010Fax: +45 70266011
Injector:	Personal Injector™
Class:	Class II
Classification Name:	Syringe Needle Introducers
Classification Panel:	General Hospital, Panel 80Regulation Number 21 C.F.R § 880.6920
Predicate Device:	Autoject 2 (K993385)Autoject 2 (K013362)
Manufacturing Facilities:	GPV Teknik A/SSmedeland 22, Albertslund2600 GlostrupDenmark

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15433696 P.Z. 22

Device Description

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 (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 (301) 443-6597 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 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

Page 1 of 1

Regulation Number and Section

§ 880.6920 Syringe needle introducer.

(a)
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.(b)
Classification. Class II (performance standards).