(90 days)
Not Found
No
The device description and intended use clearly define the product as a kit containing standard needles for injection and fluid withdrawal. There is no mention of any computational or analytical components that would suggest the use of AI or ML. The performance studies focus on physical and biological properties of the needles, not algorithmic performance.
No
The device is described as a kit of needles used for injecting or withdrawing fluids, and for drawing up fluids into a syringe. It does not perform a therapeutic function itself.
No
Explanation: The device is described as a kit containing needles for injecting or withdrawing fluids, with indications for intravitreal use, which are therapeutic or procedural functions, not diagnostic ones.
No
The device description clearly outlines physical components (needles, tray, lid) and their materials, indicating it is a hardware medical device kit, not software-only.
Based on the provided information, the Altaviz Needle Kit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to inject or withdraw fluids from the body, specifically for intravitreal use (within the eye). This is a direct interaction with the body, not the examination of specimens derived from the body.
- Device Description: The device consists of needles and a tray for holding them. These are instruments used for procedures on the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to analyze samples from the body. The Altaviz Needle Kit is used in vivo (within the body).
N/A
Intended Use / Indications for Use
The Altaviz Needle Kit is a convenience kit that includes:
A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe.
The Altaviz Needle Kit is indicated for intravitreal use.
Product codes
FMI, GAA
Device Description
The Altaviz Needle Kit is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The tray is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit.
The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin, intravitreal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, surgical setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Particulate testing of the kit components (needles) according to USP Particulate Matter in Injections and USP Particulate Matter in Ophthalmic Solutions was performed and passed. In addition, ocular irritation testing following intravitreal injection in rabbits. Ethylene oxide residuals were assessed per ISO 10993-7. Endotoxins were also tested as recommend in FDA guidance Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
December 5, 2022
Altaviz, LLC % Sean Griffin President Allied Regulatory Consulting 1540 Keller Parkway, Suite 108 #170 Keller. Texas 76248
Re: K222681
Trade/Device Name: Altaviz Needle Kit Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, GAA Dated: November 2, 2022 Received: November 2, 2022
Dear Sean Griffin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alan M.
Stevens -
S3
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222681
Device Name Altaviz Needle Kit
Indications for Use (Describe) The Altaviz Needle Kit is a convenience kit that includes:
A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe.
The Altaviz Needle Kit is indicated for intravitreal use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary - K222681
This 510(k) Summary has been prepared in accordance with 21 CFR 807.92.
Applicant
The name and address of the Applicant is:
Altaviz LLC 13766 Alton Parkway, Suite 143 Irvine, CA 92618
Application Correspondent:
Sean Griffin President Allied Regulatory Consulting 1540 Keller Parkway, Suite 108 #170 Keller, TX 76248 Phone: (817) 805-8392
Date Prepared: December 5, 2022
Device
Device Subject to this 510(k):
| Trade Name: | Altaviz Needle Kit |
|---|---|
| Common Name: | Needle Convenience Kit |
| Product Code: | FMI (Hypodermic Single Lumen Needle; 21CFR Section |
| 880.5570), GAA (Needle, Aspiration and Injection, Disposable; | |
| 21CFR Section 878.4800) | |
| Classification: | II |
Predicate Device
| 510(k) Number | Device |
|---|---|
| K082820 | K-Pack II Needle - 29g Thin Wall (Primary Predicate) |
4
Device Description
The Altaviz Needle Kit is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The tray is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit.
The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.
Indications for Use
The Altaviz Needle Kit is a convenience kit that includes:
A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe.
The Altaviz Needle Kit is indicated for intravitreal use.
Physical and Performance Characteristics
The Altaviz Needle Kit is a convenience kit of currently distributed and routinely used needles that have been combined for the convenience of the end user for use in the injection of intravitreal fluids. The Altaviz Needle Kit components (needles) are identical to the separately distributed versions and have not been changed. The included 29G injection needle is commonly used to inject intravitreal fluids and the included 5 micron filter needle is commonly used to draw up medication into a syringe prior to injection.
5
Comparison of Technological Characteristics with the Predicate Device
The Altaviz Needle Kit components are identical to the marketed predicate needle and filter needle previously distributed separately.
| Features and
Characteristics | Altaviz Needle Kit | K-Pack II Needle -
29g Thin Wall | Comparison of
Altaviz Needle Kit
and Predicate |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K222681 | K082820 | |
| Device Code | FMI, GAA | FMI | Equivalent |
| Intended Use | Used to inject fluids into, or
withdraw fluids from, parts of the
body below the surface of the
skin. | Used to inject fluids
into, or withdraw
fluids from, parts of
the body below the
surface of the skin. | Same as Predicate |
| Indications for
Use | The Altaviz Needle Kit is a
convenience kit that includes:
A 29G injection needle that is a
sterile medical device for single
use intended to inject fluids into,
or withdraw fluids from, parts of
the body below the surface of the
skin.
Either an 18G or a 19G 5 micron
filter needle that is a sterile
medical device for single use
intended to draw up fluids into a
syringe.
The Altaviz Needle Kit is
indicated for intravitreal use. | The 29G Thin Wall
K-Pack II Needle
being a Hypodermic
Single Lumen Needle
is a sterile medical
device for single use,
intended to inject
fluids into, or
withdraw fluids from,
parts of the body
below the surface of
the skin. | Equivalent. The
predicate device
indication is broad
and does not
specify intravitreal
use.
Additional testing
to intraocular
acceptance criteria
has been performed
including ethylene
oxide residuals,
endotoxin,
particulate matter
and
biocompatibility. |
| Mechanism of
Action | Manual | Manual | Identical |
| Where Used | Hospital, surgical setting | Hospital, surgical
setting | Identical |
| Packaging/
How Supplied | A convenience kit containing
previously sterilized devices | Needle provided
sterile in a blister
pouch | Equivalent |
| Materials of
Construction | Needle kit tray:
polyethylene terephthalate glycol
(PETG)
29G Needle: stainless steel and
polypropylene
18G or 19G filter needle:
stainless steel and polycarbonate | Stainless steel and
polypropylene | Identical to
predicate device
and currently
marketed filter
needle. |
| Sterility | Contains sterile (previously sterilized) devices. No additional sterilization performed prior to including in the Altaviz Needle Kit | Sterile | Identical |
6
Substantial Equivalence Discussion
The subject device is substantially equivalent to the predicate device when evaluating intended use and technological characteristics. There are no differences between the subject device and the predicate device with respect to intended use. The subject device is specifically indicated for intravitreal use while the predicate has a broad indication for all parts of the body. To support intravitreal use, ethylene oxide residuals, endotoxin, and particulate matter (see Performance Data) were tested to ensure compliance with intraocular requirements.
The technological characteristics of the 29G injection needle included in the subject device are substantially equivalent to the predicate device in that they are identical devices. The 18G or 19G 5 micron filter included in the Altaviz Needle Kit is a previously marketed class 1 device provided with the 29G injection needle for convenience of the user.
Performance Data
Particulate testing of the kit components (needles) according to USP Particulate Matter in Injections and USP Particulate Matter in Ophthalmic Solutions was performed and passed. In addition, ocular irritation testing following intravitreal injection in rabbits. Ethylene oxide residuals were assessed per ISO 10993-7. Endotoxins were also tested as recommend in FDA guidance Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.
Conclusion
The Altaviz Needle Kit is substantially equivalent to the predicate device.