(87 days)
K22681, K970370
No
The device is a simple kit containing needles for injection and fluid withdrawal. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is a needle convenience kit for injecting/withdrawing fluids, not a device that directly treats a disease or condition.
No.
The Altaviz Needle Kit II is described as a "convenience kit" containing needles intended "to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin" or "to draw up fluids into a syringe." Its intended use is for "intravitreal use" and involves the administration of substances, not the diagnosis of a condition.
No
The device is a kit containing physical needles and a tray, with no mention of software components.
Based on the provided information, the Altaviz Needle Kit II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use of Altaviz Needle Kit II: The intended use of this device is to inject or withdraw fluids from parts of the body below the surface of the skin, specifically for intravitreal use (within the eye). It is a tool for administering or collecting substances directly from the body, not for analyzing specimens outside the body.
- Device Description: The description details needles designed for piercing tissue and connecting to syringes, consistent with direct bodily interaction rather than specimen analysis.
- Performance Studies: The performance studies focus on the physical properties of the needles (particulate matter, irritation, residuals, endotoxins) and their suitability for direct use in the body, not on the accuracy or reliability of diagnostic results from analyzing specimens.
In summary, the Altaviz Needle Kit II is a medical device used for procedures involving direct interaction with the body, not for performing tests on specimens outside the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Altaviz Needle Kit II 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 II is indicated for intravitreal use.
Product codes
FMI, GAA
Device Description
The Altaviz Needle Kit II is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The original version of this kit, the Altaviz Needle Kit, was cleared on December 5, 2022 (K222681), and the only difference between the Altaviz Needle Kit and the Altaviz Needle Kit II is the 29G injection needle included.
The tray of the Altaviz Needle Kit II 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 II.
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 polycarbonate 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
Body below the surface of the skin; Intravitreal use (eye)
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, intraocular irritation testing according to ISO 10993-10 was performed and passed. 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)
K22681, K970370
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 and full name on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.
Altaviz, LLC % Sean Griffin President Allied Regulatory Consulting 1540 Keller Parkway, Suite 108 #170 Keller. Texas 76248
Re: K231261
Trade/Device Name: Altaviz Needle Kit II Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI, GAA Dated: May 1, 2023 Received: May 2, 2023
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 Advice (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,
Courtney Evans -S
Digitally signed by Courtney Evans -S Date: 2023.07.27 12:34:46 -04'00'
For CAPT Alan 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) K231261
Device Name Altaviz Needle Kit II
Indications for Use (Describe)
The Altaviz Needle Kit II 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 II is indicated for intravitreal use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Proprietary Use (Part 21 CFR 601 Subpart D) | ☐ Compassionate Use (21 CFR 601 Subpart E) |
|---|---|
| ----------------------------------------------------------------------------------------------- | -------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K231261
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: July 27, 2023
Device
Device Subject to this 510(k):
| Trade Name: | Altaviz Needle Kit II |
|---|---|
| Common Name: | Needle Convenience Kit |
| Product Code: | FMI (Needle, Hypodermic, Single Lumen; 21CFR Section 880.5570) |
| GAA (Needle, Aspiration and Injection, Disposable; 21CFR Section 878.4800) | |
| Classification: | II |
Predicate Device
| 510(k) Number | Device |
|---|---|
| K22681 | Altaviz Needle Kit |
| K970370 | TSK Steriject 29G Hypodermic Needle (Additional Predicate) |
4
Device Description
The Altaviz Needle Kit II is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The original version of this kit, the Altaviz Needle Kit, was cleared on December 5, 2022 (K222681), and the only difference between the Altaviz Needle Kit and the Altaviz Needle Kit II is the 29G injection needle included.
The tray of the Altaviz Needle Kit II 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 II.
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 polycarbonate 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 II 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.
5
The Altaviz Needle Kit II is indicated for intravitreal use.
Physical and Performance Characteristics
The Altaviz Needle Kit II 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 II 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.
| Features and
Characteristics | Proposed Altaviz
Needle Kit II | Primary Predicate
Altaviz Needle Kit | Comparison of Proposed
Device and Predicate |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231261 | K222681 | |
| Device Code | FMI, GAA | FMI, GAA | Same as Predicate |
| 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 II 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 | The Altaviz Needle
Kit II 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 | Same as Predicate
Additional testing to
intraocular acceptance
criteria for the TSK 29G
needle has been performe |
| | sterile medical
device for single
use intended to
draw up fluids into
a syringe.
The Altaviz Needle
Kit II is indicated
for intravitreal use. | sterile medical
device for single
use intended to
draw up fluids into
a syringe.
The Altaviz Needle
Kit II is indicated
for intravitreal use. | |
| Mechanism of
Action | Manual | Manual | Same as Predicate |
| Where Used | Hospital, surgical
setting | Hospital, surgical
setting | Same as Predicate |
| Kit Components | TSK Steriject
29G Hypodermic
Needle
Either an 18G or
a 19G 5 micron
filter needle | Terumo K-Pack II
29G Thin Wall
Needle
Either an 18G or a
19G 5 micron
filter needle | Same as Predicate with
exception of supplier of
injection needle |
| Packaging/
How Supplied | A convenience kit
containing
previously
sterilized devices | A convenience kit
containing
previously
sterilized devices | Same as Predicate |
| 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 or
ABS (respectively) | Needle kit tray:
polyethylene
terephthalate
glycol (PETG)
29G Needle:
stainless steel and
polypropylene
18G or 19G filter
needle: stainless
steel and
polycarbonate or
ABS (respectively) | Same as Predicate |
| Sterility | Contains Sterile
(previously
sterilized) devices.
No additional
sterilization
performed prior to
including in the
Altaviz Needle Kit
II | Contains Sterile
(previously
sterilized) devices.
No additional
sterilization
performed prior to
including in the
Altaviz Needle Kit
II | Same as Predicate |
Comparison of Technological Characteristics with the Predicate Device
6
7
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 standard hypodermic needle 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. An evaluation of biocompatibility for intravitreal injection was also conducted to ensure that the proposed device is safe for intravitreal injections.
The technological characteristics of the 29G injection needle included in the subject device are substantially equivalent to the additional predicate device in that they are identical devices. The 18G or 19G 5 micron filter included in the Altaviz Needle Kit II 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, intraocular irritation testing according to ISO 10993-10 was performed and passed. 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 II is substantially equivalent to the predicate device.