(44 days)
Not Found
No
The description focuses on mechanical and fluid dynamics for drug delivery, with no mention of AI or ML for decision-making, control, or analysis.
No
The device is a drug delivery system designed to deliver liquid medications and vaccines by penetrating the skin with a high-speed fluid jet. It does not exert its effect through pharmacological, immunological, or metabolic means, but rather provides a mechanism for administering substances that would have a therapeutic effect. Therefore, the device itself is not therapeutic.
No
The device is designed to deliver medication, not to diagnose a medical condition. Its function involves injecting substances into the subcutaneous tissue following a medical decision, not preceding it.
No
The device description clearly outlines physical components like a reusable injector, single-use medication reservoir, battery-operated vacuum source, safety switch, and inject button, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided text, the Avant Guardian™ 101 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "deliver various liquid medications and vaccines by penetrating the skin with a high-speed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue." This describes a device used for administering substances into the body, not for testing samples from the body.
- Device Description: The description details a mechanism for injecting medication subcutaneously. It involves a medication reservoir, an injector, vacuum, and a fluid jet. This is consistent with a drug delivery device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Avant Guardian™ 101's function is purely for administering medication.
N/A
Intended Use / Indications for Use
The Avant Guardian™ 101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a high-speed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.
Product codes
KZE
Device Description
The Avant Guardian™ 101 allows a medication or vaccine to be injected subcutaneously without the use of a needle. The system is designed to mimic the best clinical practices for iniecting medications, namely, a slow injection of medication into tissue that is not compressed.
The product consists of a single-use medication reservoir (syringe) and a reusable injector. The operator employs an offthe-shelf vial adapter to fill the single-use medication reservoir with medication. The injector device is reset by compressing the spring-loaded push-rod. The medication reservoir is then placed in the Avant injector, which has an integral, batteryoperated vacuum source. The patient places the reservoir against his skin and activates the vacuum by depressing the safety switch. To prevent an accidental discharge, the safety switch must be depressed and held until the injection is initiated by the operator depressing the inject button. As the vacuum is formed, skin is drawn up to and securely held in contact with the reservoir tip. Suction generated by the injector stabilizes the reservoir against the patient's skin to create a subcutaneous pocket (thereby avoiding muscle), eliminating the need to force the injector against the skin and compress the underlying tissue. The suction creates a seal around the tip that allows slow delivery of the medication, and stabilizes the device to prevent lacerations and movement of the orifice.
The medication is delivered in two stages. The patient depresses the inject button, causing a mechanism in the device to impact the medication reservoir plunger. Initially a high pressure, high speed jet of medication exits the reservoir orifice, puncturing the skin and the underlying tissue. The injection force quickly falls to a low level as the spring-loaded mechanism forces the medication into the subcutaneous tissue. The injector automatically stops the vacuum pump at the end of the injection, thereby indicating when the injector can be removed from the skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Extensive design verification, functional and performance testing have been conducted on the Avant Guardian™ 101 to demonstrate its ability to safely and effectively deliver injections similar to currently marketed jet injectors. The Avant Guardian™ 101 successfully completed the following tests:
- Biocompatibility testing per ISO 10993 requirements .
- Design verification tests to confirm product integrity .
- Side-by-side performance testing using a tissue model ● and simulated skin test chamber
- . Risk analysis
Key Metrics
Not Found
Predicate Device(s)
K960373, K920631, K962956, K994384, K945873
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).
0
KO24616 Rage Lo& 3
JAN 1 7 2003
3914 Kendall Street San Diego, CA 92109 Phone: (858) 273-3674 Fax: (858) 274-6744 jslate@san.rr.com
Image /page/0/Picture/3 description: The image shows the logo for Avant Medical Corporation. The word "avant" is in large, bold, sans-serif font. Below it, in smaller font, are the words "MEDICAL CORPORATION". The logo is black and white.
SUMMARY OF SAFETY AND EFFECTIVENESS
AVANT MEDICAL CORPORATION
Avant Guardian™ 101
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Company: | Avant Medical Corporation
3914 Kendall Street
San Diego, CA 92109
Tel: (858) 273-3674
Fax: (858) 274-6744 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Company Representative: | John B. Slate, Ph.D.
Sr. Vice President, Operations |
| Date 510(k) Prepared: | 3 December 2002 |
| Device Name: | Avant Guardian TM 101 |
| Common Name: | Needle-free injection system |
| Classification Panel: | General Hospital |
| Classification Name: | Nonelectrically Powered Fluid Injector |
| Product Code: | KZE |
| CFR Section: | 880.5430 |
| Classification: | Class II |
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Devices to Which Substantial Equivalence is Claimed:
Avant Guardian™ 101 is substantially equivalent to the following currently marketed jet injectors:
- Bioject Biojector 2000 (K960373, K920631) .
- . Medi-Ject Vision (modification of the Medi-Ject Choice, K962956 and K994384)
- Equidyne Injex 30 (K945873) .
Device Description:
The Avant Guardian™ 101 allows a medication or vaccine to be injected subcutaneously without the use of a needle. The system is designed to mimic the best clinical practices for iniecting medications, namely, a slow injection of medication into tissue that is not compressed.
The product consists of a single-use medication reservoir (syringe) and a reusable injector. The operator employs an offthe-shelf vial adapter to fill the single-use medication reservoir with medication. The injector device is reset by compressing the spring-loaded push-rod. The medication reservoir is then placed in the Avant injector, which has an integral, batteryoperated vacuum source. The patient places the reservoir against his skin and activates the vacuum by depressing the safety switch. To prevent an accidental discharge, the safety switch must be depressed and held until the injection is initiated by the operator depressing the inject button. As the vacuum is formed, skin is drawn up to and securely held in contact with the reservoir tip. Suction generated by the injector stabilizes the reservoir against the patient's skin to create a subcutaneous pocket (thereby avoiding muscle), eliminating the need to force the injector against the skin and compress the underlying tissue. The suction creates a seal around the tip that allows slow delivery of the medication, and stabilizes the device to prevent lacerations and movement of the orifice.
The medication is delivered in two stages. The patient depresses the inject button, causing a mechanism in the device to impact the medication reservoir plunger. Initially a high pressure, high speed jet of medication exits the reservoir orifice, puncturing the skin and the underlying tissue. The injection force quickly falls to a low level as the spring-loaded mechanism forces the medication into the subcutaneous tissue. The injector automatically stops the vacuum pump at the end of the injection, thereby indicating when the injector can be removed from the skin.
2
Intended Use:
The Avant Guardian™ 101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a highspeed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.
Summary of Technological Characteristics Compared to Predicate Devices:
Extensive design verification, functional and performance testing have been conducted on the Avant Guardian™ 101 to demonstrate its ability to safely and effectively deliver injections similar to currently marketed jet injectors. The Avant Guardian™ 101 successfully completed the following tests:
- Biocompatibility testing per ISO 10993 requirements .
- Design verification tests to confirm product integrity .
- Side-by-side performance testing using a tissue model ● and simulated skin test chamber
- . Risk analysis
The results indicate that the Avant Guardian™ 101 presents no new issues of safety when compared to the predicate devices.
The sponsor believes that the data submitted for the Avant Guardian™ 101 constitutes valid scientific evidence to support safety and effectiveness. The sponsor believes that the Guardian is safe and effective when used according to the device labeling.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces, and a wing-like shape extending from the back of the head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Dr. John B. Slate Avant Medical Corporation 3914 Kendall Street San Diego, California 92109
Re: K024018
Trade/Device Name: Avant Guardian™ 101 Needle Free Injection System Regulation Number: 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: December 3, 2002 Received: December 4, 2002
Dear Dr. Slate:
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 - Dr. Slate
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 vour 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Uhlmann
Timothy A. Ulatowski 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Avant Guardian™ 101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a high-speed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use __________
Patricia Ciccarelli
f Anesthesiology, General Hospital. Infection Control, Den
510(k) Number: K024418
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