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.

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.

AI/ML Overview

The Altaviz Needle Kit II is a convenience kit consisting of a 29G injection needle and either an 18G or 19G 5 micron filter needle. The device is indicated for intravitreal use. The provided text outlines the substantial equivalence argument for this device, comparing it to a primary predicate (Altaviz Needle Kit) and an additional predicate (TSK Steriject 29G Hypodermic Needle). The acceptance criteria and the study proving the device meets these criteria are primarily focused on the performance of the individual components, specifically the 29G injection needle, for intravitreal use, as the "kit" itself is a convenience packaging of pre-sterilized, previously distributed needles.

Here's a breakdown of the information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance tests conducted to support the device's suitability for intravitreal use, specifically for the 29G injection needle. The text states that "Additional testing to intraocular acceptance criteria for the TSK 29G needle has been performed." and details these tests under "Performance Data".

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Particulate Matter	USP <788> Particulate Matter in Injections	Meets specified limits for particulate matter in injections (general)	Passed
	USP <789> Particulate Matter in Ophthalmic Solutions	Meets specified limits for particulate matter in ophthalmic solutions (specific to eye)	Passed
Biocompatibility/Irritation	ISO 10993-10 (Intraocular Irritation Testing)	No unacceptable intraocular irritation	Passed
Ethylene Oxide (EtO) Residuals	ISO 10993-7	Residual EtO levels within specified safe limits	Assessed (and implicitly passed to support clearance)
Endotoxins	FDA guidance "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices"	Endotoxin levels within specified safe limits for intraocular devices	Tested (and implicitly passed to support clearance)

Note on "Implicit" Acceptance Criteria: The document states that the tests were performed and "passed," implying that the device met the established acceptance criteria for those standards. The specific numerical limits for these standards (e.g., maximum particulate count, EtO limits, endotoxin levels) are not explicitly stated in this summary but are defined within the referenced ISO and USP standards and FDA guidance documents.

2. Sample Size and Data Provenance

Sample Size for Test Set: The sample sizes for the specific performance tests (particulate, irritation, EtO residuals, endotoxins) are not explicitly stated in this document. These would typically be detailed in the full test reports referenced by the standards (e.g., ISO, USP).
Data Provenance: Not explicitly stated from the provided text. The tests were performed to demonstrate compliance with international standards (ISO, USP) and FDA guidance, suggesting a controlled laboratory testing environment, but the country of origin of the data or whether it was retrospective/prospective is not specified. Given it's premarket notification, it's typically prospective testing.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable/not stated. For a medical device focused on physical and chemical characteristics, the "ground truth" is established by adherence to validated laboratory testing methods and compliance with established international standards (ISO, USP) and FDA guidance. The evaluation does not involve medical interpretation by experts in the same way an AI diagnostic algorithm for images would.
Qualifications of Experts: Not applicable/not stated. The "experts" in this context would be the technicians and scientists performing the tests, qualified to conduct analyses according to the specified standards, but their specific qualifications are not detailed here.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 consensus) is relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies need to be resolved. For laboratory performance testing against predefined standards, there is no "adjudication" in this sense; the results either meet the criteria or they do not.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is typically performed for AI-assisted diagnostic devices to evaluate how AI assistance impacts human reader performance. The Altaviz Needle Kit II is a physical medical device, not a diagnostic AI tool, so an MRMC study is not relevant.

6. Standalone Performance (Algorithm Only)

Standalone Performance: No. This concept applies to AI algorithms. The performance evaluation here is of the physical device components themselves meeting safety and performance standards for their intended use.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth is established by objective laboratory measurements and tests against predefined, quantitative, and qualitative criteria within established international standards (ISO, USP) and FDA guidance. For example, the ground truth for particulate matter is the measured particulate count compared to the maximum allowable count, and for irritation, it's the observed biological response compared to predefined irritation scales.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no "training set." The components of the kit are physical devices that undergo manufacturing and quality control processes to ensure consistency and compliance.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set.

Summary

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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

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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

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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)
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☒ 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)

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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)

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Device Description

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.

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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 andCharacteristics	Proposed AltavizNeedle Kit II	Primary PredicateAltaviz Needle Kit	Comparison of ProposedDevice and Predicate
510(k) Number	K231261	K222681
Device Code	FMI, GAA	FMI, GAA	Same as Predicate
Intended Use	Used to injectfluids into, orwithdraw fluidsfrom, parts of thebody below thesurface of the skin.	Used to inject fluidsinto, or withdrawfluids from, parts ofthe body below thesurface of the skin	Same as Predicate
Indications forUse	The Altaviz NeedleKit II is aconvenience kitthat includes:A 29G injectionneedle that is asterile medicaldevice for singleuse intended toinject fluids into,or withdraw fluidsfrom, parts of thebody below thesurface of the skin.Either an 18G or a19G 5 micron filterneedle that is a	The Altaviz NeedleKit II is aconvenience kit thatincludes:A 29G injectionneedle that is asterile medicaldevice for singleuse intended toinject fluids into, orwithdraw fluidsfrom, parts of thebody below thesurface of the skin.Either an 18G or a19G 5 micron filterneedle that is a	Same as PredicateAdditional testing tointraocular acceptancecriteria for the TSK 29Gneedle has been performe
	sterile medicaldevice for singleuse intended todraw up fluids intoa syringe.The Altaviz NeedleKit II is indicatedfor intravitreal use.	sterile medicaldevice for singleuse intended todraw up fluids intoa syringe.The Altaviz NeedleKit II is indicatedfor intravitreal use.
Mechanism ofAction	Manual	Manual	Same as Predicate
Where Used	Hospital, surgicalsetting	Hospital, surgicalsetting	Same as Predicate
Kit Components	TSK Steriject29G HypodermicNeedleEither an 18G ora 19G 5 micronfilter needle	Terumo K-Pack II29G Thin WallNeedleEither an 18G or a19G 5 micronfilter needle	Same as Predicate withexception of supplier ofinjection needle
Packaging/How Supplied	A convenience kitcontainingpreviouslysterilized devices	A convenience kitcontainingpreviouslysterilized devices	Same as Predicate
Materials ofConstruction	Needle kit tray:polyethyleneterephthalateglycol (PETG)29G Needle:stainless steel andpolypropylene18G or 19G filterneedle: stainlesssteel andpolycarbonate orABS (respectively)	Needle kit tray:polyethyleneterephthalateglycol (PETG)29G Needle:stainless steel andpolypropylene18G or 19G filterneedle: stainlesssteel andpolycarbonate orABS (respectively)	Same as Predicate
Sterility	Contains Sterile(previouslysterilized) devices.No additionalsterilizationperformed prior toincluding in theAltaviz Needle KitII	Contains Sterile(previouslysterilized) devices.No additionalsterilizationperformed prior toincluding in theAltaviz Needle KitII	Same as Predicate

Comparison of Technological Characteristics with the Predicate Device

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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 <788> Particulate Matter in Injections and USP <789> 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.

Regulation Number and Section

§ 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).