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.

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.

AI/ML Overview

The Altaviz Needle Kit is a convenience kit containing a 29G injection needle and either an 18G or 19G 5-micron filter needle. The kit is intended for intravitreal use. The provided text describes the performance data and criteria used to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Particulate Matter	USP <788> Particulate Matter in Injections: Likely refers to limits on the number of particles of specific sizes (e.g., ≥10 µm, ≥25 µm) per container for parenteral preparations. The specific limits would depend on the volume of the injection. USP <789> Particulate Matter in Ophthalmic Solutions: Refers to limits on the number of particles of specific sizes (e.g., ≥10 µm, ≥25 µm, ≥50 µm) per mL or per container for ophthalmic preparations.	Particulate testing of the kit components (needles) according to USP <788> and USP <789> was performed and passed. This indicates that the device met the specified particulate matter limits for both injections (parenteral) and ophthalmic solutions, ensuring suitability for intravitreal use where particulate load is critical.
Ethylene Oxide (EtO) Residuals	ISO 10993-7: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals: Specifies allowable limits for EtO residuals (ethylene oxide, ethylene chlorohydrin, and ethylene glycol) in medical devices after sterilization, particularly for devices with limited or prolonged contact with patients. The specific limits depend on the device's application and contact duration. For intravitreal use, very low limits are typically required due to the sensitivity of ocular tissues.	Ethylene oxide residuals were assessed per ISO 10993-7. The implication is that the device met the specified residual limits for EtO. Given the intravitreal indication, this would necessarily mean meeting the stringent requirements for devices with limited contact but high sensitivity, ensuring no toxic levels of EtO byproducts are present.
Endotoxins	FDA guidance "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices": This guidance typically specifies a maximum endotoxin limit (e.g., Endotoxin Units per device or per mL of extract) for intraocular devices to prevent inflammation or adverse reactions in the eye. A common limit for intraocular devices is usually 0.5 EU/mL or 2.5 EU/device.	Endotoxins were tested as recommended in FDA guidance "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices." The successful testing implies that the device met the specified endotoxin limits, critical for preventing pyrogenic reactions and inflammation when introduced into the eye.
Ocular Irritation	Invivo animal study (rabbits) for intravitreal injection: This criterion would assess the biocompatibility and safety of the device components when introduced into the vitreous. It involves evaluating for signs of inflammation, tissue damage, or adverse reactions in the ocular tissues of the test animals over a specified period. The acceptance criterion would be the absence of significant or unacceptable irritation/toxicity compared to a control.	Ocular irritation testing following intravitreal injection in rabbits was performed. This test indicates that the device components did not induce unacceptable irritation or adverse reactions when directly injected into the eyes of rabbits, supporting its safety for human intravitreal use from a biocompatibility standpoint.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (particulate matter, EtO residuals, endotoxins, ocular irritation). These details are typically found in the full test reports, which are not included in this 510(k) summary.

The data provenance is from laboratory testing performed specifically for this device (Altaviz Needle Kit). The type of test (e.g., animal study for ocular irritation, chemical analysis for EtO) implies prospective testing, as the device was manufactured and then subjected to these evaluations to demonstrate compliance. The country of origin of the data is not specified, but given the FDA submission, the testing would have been conducted in a facility adhering to recognized international standards and good laboratory practices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is typically not applicable to objective chemical, physical, and biocompatibility tests like those described.

Particulate Matter, EtO Residuals, Endotoxins: These involve standardized laboratory tests with objective measurable endpoints. "Ground truth" is established by the validated test methods and reference standards themselves, not by expert consensus.
Ocular Irritation: While interpreted by pathologists or veterinarians, the "ground truth" here is the observed biological response in the animal model as assessed against defined criteria for irritation/toxicity. The document does not specify the number or qualifications of experts involved in the interpretation of the rabbit study results, but it would typically involve board-certified veterinary pathologists or toxicologists.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements (e.g., particle counts, chemical concentrations, endotoxin levels) or standardized biological evaluations (animal studies) that rely on established protocols and quantitative/semi-quantitative assessments rather than human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI-assisted diagnostic tools where human readers interpret medical images with and without AI assistance. The Altaviz Needle Kit is a physical medical device (needles) for injection, and its performance is evaluated through material science, chemical, and biological safety testing, not through human reader interpretation of images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way, the standalone performance of the device components was assessed. The performance data focuses entirely on the intrinsic properties and safety of the needles themselves (particulate matter, EtO residuals, endotoxins, ocular irritation). There is no "human-in-the-loop" aspect to these specific performance evaluations as they assess the device's inherent characteristics against safety and quality standards.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation can be summarized as:

Standardized Analytical Thresholds/Limits: For Particulate Matter (USP <788>, <789>), Ethylene Oxide Residuals (ISO 10993-7), and Endotoxins (FDA guidance), the "ground truth" is defined by the established regulatory and consensus standard limits that the device must meet.
Biological Response in an Animal Model: For Ocular Irritation, the "ground truth" is the observed biological safety (lack of significant adverse tissue reaction) in a validated animal model (rabbits) following direct intravitreal injection. This is a form of outcomes data in a preclinical setting.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning or AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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

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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 (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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Section880.5570), 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)

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Device Description

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.

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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 andCharacteristics	Altaviz Needle Kit	K-Pack II Needle -29g Thin Wall	Comparison ofAltaviz Needle Kitand Predicate
510(k) Number	K222681	K082820
Device Code	FMI, GAA	FMI	Equivalent
Intended Use	Used to inject fluids into, orwithdraw fluids from, parts of thebody below the surface of theskin.	Used to inject fluidsinto, or withdrawfluids from, parts ofthe body below thesurface of the skin.	Same as Predicate
Indications forUse	The Altaviz Needle Kit is aconvenience kit that includes:A 29G injection needle that is asterile medical device for singleuse intended to inject fluids into,or withdraw fluids from, parts ofthe body below the surface of theskin.Either an 18G or a 19G 5 micronfilter needle that is a sterilemedical device for single useintended to draw up fluids into asyringe.The Altaviz Needle Kit isindicated for intravitreal use.	The 29G Thin WallK-Pack II Needlebeing a HypodermicSingle Lumen Needleis a sterile medicaldevice for single use,intended to injectfluids into, orwithdraw fluids from,parts of the bodybelow the surface ofthe skin.	Equivalent. Thepredicate deviceindication is broadand does notspecify intravitrealuse.Additional testingto intraocularacceptance criteriahas been performedincluding ethyleneoxide residuals,endotoxin,particulate matterandbiocompatibility.
Mechanism ofAction	Manual	Manual	Identical
Where Used	Hospital, surgical setting	Hospital, surgicalsetting	Identical
Packaging/How Supplied	A convenience kit containingpreviously sterilized devices	Needle providedsterile in a blisterpouch	Equivalent
Materials ofConstruction	Needle kit tray:polyethylene terephthalate glycol(PETG)29G Needle: stainless steel andpolypropylene18G or 19G filter needle:stainless steel and polycarbonate	Stainless steel andpolypropylene	Identical topredicate deviceand currentlymarketed filterneedle.
Sterility	Contains sterile (previously sterilized) devices. No additional sterilization performed prior to including in the Altaviz Needle Kit	Sterile	Identical

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

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).