The INUMI™ Flex Needle (subject device) is an endoscopically compatible soft tissue ablation device that is used as part of the 510(k)-cleared Aliya™ System (K212871). The subject device has a 160 cm working length, and is compatible with endoscope working channels with a minimum of 2.0 mm diameter.

AI/ML Overview

This is a 510(k) premarket notification for the INUMI™ Flex Needle, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria typically associated with AI/ML device performance. Therefore, many of the requested details related to AI/ML device studies (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set details) are not applicable or not provided in this regulatory submission.

However, based on the provided text, I can extract information related to the performance testing conducted for this medical device to demonstrate its safety and effectiveness.

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a direct table of specific numerical acceptance criteria. Instead, it describes various performance tests conducted and generally states that the device "demonstrated compliance," "conforms to predefined specifications," or "supports a determination of substantial equivalence."

Category	Acceptance Criteria (Implicit/General Statement)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 and FDA Guidance on "Biological Evaluation of Medical Devices" for patient-contacting components.	"Biocompatibility testing was performed for patient-contacting components of the INUMI™ Flex Needle in accordance with ISO 10993-1 requirements, as well as the FDA Guidance Document... September 2023." (Implies compliance was achieved).
Sterilization	Achieve a sterility assurance level (SAL) of 10-6 using ethylene oxide sterilization per ISO 11135:2014.	"The INUMI™ Flex Needle was validated per ISO 11135:2014 to achieve a sterility assurance level of 10-6 using ethylene oxide sterilization."
Shelf-Life/Package Validation	Maintain package integrity and sterility, in accordance with applicable standards (ASTM F1980-21, ISTA 3A 2018, ASTM F2096-11, ASTM F1929-15, ASTM F88/F88M-21).	"Shelf-Life and Package Validation were performed to ensure that the devices maintain package integrity and sterility. Applicable standards were used..." (Implies successful maintenance).
Electrical Safety and EMC	Compliance with applicable standards, including IEC 60601-1 and IEC 60601-1-2.	"Electrical safety and EMC testing was completed for the applicable components of the INUMI™ Flex Needle. The results demonstrated compliance to all applicable standards, including IEC 60601-1 and IEC 60601-1-2."
Capacitive Coupling	Compliance with applicable clauses of IEC 60601-2-18, per FDA Guidance on Premarket Notifications (510(k)) Submissions for Electrosurgical Devices for General Surgery.	"Capacitive coupling testing was done per FDA Guidance... according to the applicable clauses of IEC 60601-2-18." (Implies compliance was achieved).
Mechanical & Electrical Performance	Conformance to predefined mechanical and electrical specifications after sterilization and accelerated aging.	"Mechanical and Functional testing was completed to confirm that the performance of the INUMI™ Flex Needle conforms to the predefined mechanical and electrical specifications after sterilization and accelerated aging."
Ex Vivo Thermal Effects (Tissue)	Measurement of temperature-time history consistent with FDA Guidance, with comparative testing demonstrating substantial equivalence.	"The temperature-time history was measured consistent with the recommendations of the FDA Guidance... in three types of ex-vivo porcine tissue - liver, kidney, and muscle. Comparative testing was performed with the subject device and the primary predicate device." (Implies favorable comparison).
Comparative Ablation Performance (Animal Model)	Characterize tissue destruction with subject device and primary predicate device in accordance with FDA guidance, supporting substantial equivalence.	"Porcine model was utilized to characterize tissue destruction with subject device and the primary predicate device in the liver, kidney, and longissimus dorsi skeletal muscle in accordance with the FDA quidance..." (Implies favorable characterization and comparison).
Endoscopic Performance (Animal Model)	Evaluate navigation, access, and ablation of target tissues during endoscopic use.	"A chronic porcine GLP study was conducted to evaluate the performance of the endoscopic use of subject device regarding navigation, access, and ablation of target tissues." (Implies successful evaluation and performance).

2. Sample size used for the test set and the data provenance:

Biocompatibility: Not specified as a numerical sample size. Testing was performed on "patient-contacting components."
Sterilization: Not specified (often involves multiple runs/batches to reach SAL 10^-6).
Shelf-Life/Package Validation: Not specified (typically involves multiple packages/units).
Electrical Safety, EMC, Capacitive Coupling, Mechanical/Electrical Performance: Not specified (typically involves a representative number of devices or components).
Ex Vivo Characterization of Thermal Effects on Tissue: Tested in "three types of ex-vivo porcine tissue - liver, kidney, and muscle." The number of samples per tissue type is not specified. Data Provenance: Ex-vivo porcine tissue.
Comparative Ablation Performance (Animal): A "Porcine model" was utilized. The number of animals or specific lesions is not stated. Data Provenance: Porcine (animal model).
Endoscopic Performance (Animal): A "chronic porcine GLP study" was conducted. The number of animals is not stated. Data Provenance: Porcine (animal model), GLP study (implying prospective, controlled experimental design).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies described are primarily engineering, chemical, and animal studies, not interpretative studies requiring human expert consensus for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or challenging diagnoses, which is not the primary focus of the performance tests outlined here for a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an electrosurgical needle, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the various performance tests is established through:

Compliance with validated standards: For biocompatibility (ISO 10993-1), sterilization (ISO 11135), electrical safety (IEC 60601 series), package integrity (ASTM/ISTA standards).
Predefined mechanical and electrical specifications: For mechanical and electrical performance.
Direct measurement and observation: For thermal effects on tissue (temperature-time history), tissue destruction, navigation, access, and ablation endpoints in animal models.
Comparison to predicate device: For performance aspects where substantial equivalence is being demonstrated.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:

This is not applicable as this is not an AI/ML device.

Summary

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May 22, 2024

Galvanize Therapeutics, Inc. Dongbo Wang Senior Director of Regulatory Affairs 3200 Bridge Parkway Redwood City, California 94065

Re: K233884

Trade/Device Name: INUMI™ Flex Needle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OAB Dated: May 20, 2024 Received: May 20, 2024

Dear Dongbo Wang:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Long H. Chen =S Digitally signed by Long H.Chen -S

Date: 2024.05.22 Date: 2024.05.22 08:59:39 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233884

Device Name

INUMI™ Flex Needle

Indications for Use (Describe)

The INUMI™ Flex Needle is intended for use as part of the Aliya™ System for surgical ablation of soft tissue.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Date of 510(k) Summary Preparation: 11 April 2023

Submitter Information

Manufacturer:	Galvanize Therapeutics, Inc.3200 Bridge Pkwy,Redwood City, CA 94065Phone: 650-268-4252Fax: N/A
Contact:	Dongbo WangSenior Director of Regulatory Affairsdwang@galvanizetx.comPhone: 650-268-4252

Subject Device

Device Trade Name:	INUMIT™ Flex Needle
510(k) Number:	K233884
Common Name:	Low energy soft tissue ablation device
Regulation Number:	21 CFR §878.4400
Regulation Name:	Electrosurgical cutting and coagulation device and accessories
Product Code:	OAB low energy direct current thermal ablation system
Review Panel:	General & Plastic Surgery (SU)

Primary Predicate Device

Device Trade Name:	Aliya™ System
510(k) Number	K212871
Manufacturer:	Galvanize Therapeutics

Device Description

Proposed Indications for Use statement

The INUMI™ Flex Needle is intended for use as part of the Aliya™ System for surgical ablation of soft tissue.

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Comparison to Primary Predicate Device

Characteristic	INUMI™ Flex NeedleSubject Device	Aliya™ SystemPrimary PredicateDevice	Comparison
510(k) number	TBD (K233884)	K212871	N/A
ClassificationRegulation	21 CFR §878.4400Electrosurgical cuttingand coagulation deviceand accessories.	21 CFR §878.4400Electrosurgical cuttingand coagulation deviceand accessories.	Identical
Product Code	OAB low energy directcurrent thermalablation system	OAB low energy directcurrent thermal ablationsystem	Identical
Indications for Usestatement	The INUMI™ FlexNeedle is intended foruse as part of theAliya™ System forsurgical ablation of softtissue.	The Aliya™ System isindicated for the surgicalablation of soft tissue.	Identical, for surgical ablationof soft tissue, subject devicespecifies compatibility with theAliya System
Intended use	Ablation of soft tissue	Ablation of soft tissue	Identical
Type of Use	Prescription	Prescription	Identical
Energy Source	Galvanize Aliya™Generator (K212871) –Pulsed Electric Field	Galvanize Aliya™Generator (K212871) –Pulsed Electric Field	Identical
Energy Polarity	Monopolar	Monopolar	Identical
Electrode	Aliya™ Electrode(K212871)	Aliya™ Electrode(K212871)	Identical
Access	Endoscopic	Percutaneous	Different

Comparison of Indications for Use statement with the Primary Predicate Device

The Indications for Use statements are identical in that both devices (predicate and subject devices) are indicated for the surgical ablation of soft tissue. The Indication for Use statement for the subject device adds the specificity for the compatibility with the Aliya System. The additional language defining compatibility does not alter or expand the intended use, it is a technical limitation on compatible devices.

Comparison of Technological Characteristics with the Primary Predicate Device

The subject device and the primary predicate device utilize the same generator and electrode to achieve soft tissue ablation. The main difference in technological characteristics is the form of access - endoscopic for the subject device and percutaneous for the predicate device.

Performance Testing (bench)

Performance testing has been completed to demonstrate (in part) substantial equivalence of the subject device to the predicate device. The testing performed is summarized, below:

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Biocompatibility

Biocompatibility testing was performed for patient-contacting components of the INUMI™ Flex Needle in accordance with ISO 10993-1 requirements, as well as the FDA Guidance Document Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," September 2023.

Sterilization

The INUMI™ Flex Needle was validated per ISO 11135:2014 to achieve a sterility assurance level of 10-6 using ethylene oxide sterilization.

Shelf-Life/Package Validation

Shelf-Life and Package Validation were performed to ensure that the devices maintain package intecrity and sterility. Applicable standards were used: ASTM F1980-21, ISTA 3A 2018, ASTM F2096-11, ASTM F1929-15, ASTM F88/F88M-21.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing was completed for the applicable components of the INUMI™ Flex Needle. The results demonstrated compliance to all applicable standards, including IEC 60601-1 and IEC 60601-1-2.

Capacitive Couple Testing

Capacitive coupling testing was done per FDA Guidance on Premarket Notifications (510(k)) Submissions for Electrosurgical Devices for General Surgery according to the applicable clauses of IEC 60601-2-18.

Mechanical and Electrical Performance Testing

Mechanical and Functional testing was completed to confirm that the performance of the INUMI™ Flex Needle conforms to the predefined mechanical and electrical specifications after sterilization and accelerated aging.

Ex Vivo Characterization of Thermal Effects on Tissue

The temperature-time history was measured consistent with the recommendations of the FDA Guidance on Premarket Notification (510(k)) Submission for Electrosurgical Devices for General Surgery in three types of ex-vivo porcine tissue - liver, kidney, and muscle. Comparative testing was performed with the subject device and the primary predicate device.

Performance Testing (animal)

Comparative Ablation Performance

Porcine model was utilized to characterize tissue destruction with subject device and the primary predicate device in the liver, kidney, and longissimus dorsi skeletal muscle in accordance with the FDA quidance on Premarket Notification [510(k)] for Electrosurgical Devices for General Surgery.

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Endoscopic Performance

A chronic porcine GLP study was conducted to evaluate the performance of the endoscopic use of subject device regarding navigation, access, and ablation of target tissues.

Conclusion

The subject INUMI™ Flex Needle and the legally marketed predicate Aliya™ System (K212871) share the same Intended Use and consistent Indications for Use. Both performance testing (bench) and performance testing (animal) support a determination of substantial equivalence to the legally marketed predicate device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.