The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.

Device Description

The Chocolate PTA Balloon Catheter is an "over-the-wire" balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The product family consists of 0.014" and 0.018" systems that are compatible with 0.014" and 0.018" guidewires, respectively. Overall catheter lengths range from 120-150 cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is constrained by a nitinol constraining structure (CS) which provides fast deflation and uniform re-wrap. Upon deflation, the CS is removed from the vessel along with the balloon catheter. The balloon is available in multiple sizes and contains two radiopaque markers to assist with positioning. The proximal end of the device is a common balloon catheter design of a braided shaft connected to a plastic hub and strain relief. The hub has two ports; the balloon port is used to inflate the balloon and the guidewire port connects to the guidewire lumen.

The Chocolate PTA balloon catheter is intended for single-use only and is provided sterile and non-pyrogenic.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medtronic Chocolate PTA Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a comprehensive de novo clinical trial with defined acceptance criteria and extensive performance studies.

Therefore, the document does not contain the information typically found in a study proving a device meets acceptance criteria, such as:

A table of acceptance criteria and reported device performance: The submission focuses on comparing the new device's characteristics to a predicate, not on setting and meeting specific quantitative performance metrics like sensitivity, specificity, or accuracy.
Sample sizes used for the test set and data provenance: No clinical test set involving patients or human data is described for performance evaluation.
Number of experts used to establish ground truth or their qualifications: Ground truth establishment is not relevant in this type of submission, as it's about equivalence, not novel performance claims.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI-assisted diagnostic device, nor is it a study comparing human performance with and without the device.
Standalone (algorithm only) performance: Not applicable as this is a medical device (balloon catheter), not an algorithm or AI.
Type of ground truth used: Not applicable.
Sample size for the training set and how ground truth for training set was established: Not applicable, as this is a physical medical device, not an AI/ML algorithm.

What the document does describe in terms of "proving acceptance criteria":

The "acceptance criteria" in the context of this 510(k) submission are not performance metrics for clinical efficacy, but rather the demonstration of substantial equivalence to an existing predicate device. The "study that proves the device meets the acceptance criteria" refers to the various tests and analyses performed to support this equivalence.

Here's an interpretation based on the provided text:

Implicit Acceptance Criteria (for 510(k) Substantial Equivalence):

The implied acceptance criteria for this 510(k) submission are that the modified Chocolate PTA Balloon Catheter is as safe and effective as the predicate device (Chocolate PTA Balloon Catheter K130414) and does not raise new questions of safety or effectiveness. This is demonstrated by showing:

Identical/Similar Intended Use: The intended use is largely the same, with a minor change in the exclusion of renal arteries.
Equivalent Technological Characteristics: Key design principles, balloon specifications, and catheter technical specifications remain identical or acceptably similar.
Biocompatibility: The device is biocompatible and safe for patient contact.
Sterilization: The sterilization method is unchanged and validated.
Packaging: Packaging changes do not compromise sterility or device integrity.

The "Study" (Evidence) Proving the Device Meets These Implicit Acceptance Criteria:

The "study" in this context is a compilation of various non-clinical testing and comparisons.

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for 510(k)): Demonstration of substantial equivalence to the predicate device (K130414) for the Chocolate PTA Balloon Catheter. This is assessed by comparing intended use, technological characteristics, and performance data to ensure safety and effectiveness are maintained.
- Reported Device Performance (as described in the document):
  - Intended Use: "The Chocolate PTA balloon catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries." (Note: this is a slight modification from the predicate, which also included renal arteries). The change does not introduce new safety concerns.
  - Technological Characteristics:
    - Identical: Intended Use (largely), Principle of Operation, Balloon technical specifications (diameters, lengths, materials, markers, burst pressure, nominal pressure, constraining structure material), Catheter technical specifications (lengths, guidewire/introducer compatibility, most materials), Packaging materials, Testing and Compliance to ISO 10993 and ISO 11135-1, Sterilization Method.
    - Similar (with justification for equivalence): Inner Member components (resin changes in outer and inner layers, tie-layer unchanged), IFU specifications (size, stitching), Compliance Card size/artwork, Pouch Label dimensions, Carton Label dimensions.
  - Biocompatibility: Passed required tests per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Hemocompatibility). No new or increased biocompatibility concerns.
  - Packaging Validation: Passed packaging validation, packaging aging, and sterilization testing with a worst-case 72-page IFU and eIFU leaflet. No additional risks identified.
  - Sterilization: Successfully completed testing indicated no sterilization process changes required. Sterilization assurance level 10-6 maintained.
  - Performance Equivalence Conclusion: "The technological characteristics and performance criteria of the Chocolate PTA Balloon Catheter are equivalent to the predicate device, and the subject device performs in a manner equivalent to the predicate device currently on the market."
Sample sizes used for the test set and the data provenance:
- This document describes non-clinical testing (e.g., biocompatibility testing on material samples, packaging validation on multiple units). It does not specify "sample sizes" in terms of clinical patient populations.
- Data Provenance: Not explicitly stated, but typical for medical device testing to be conducted at manufacturer facilities or contracted laboratories. No mention of country of origin for any human data (as none was used). The testing is retrospective in the sense that it supports the premarket notification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the diagnostic sense is not established for this device's performance given the 510(k) pathway. Expert knowledge would be involved in designing and interpreting the engineering and material safety tests, but not in diagnosing conditions.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as this is not a diagnostic imaging study requiring multi-reader adjudication.
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:
- No. This is a physical medical device (balloon catheter), not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device (balloon catheter), not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the clinical diagnostic sense. The "ground truth" for this submission is based on established engineering principles, material science, validated test methods (e.g., ISO standards), and a comparison to the known performance and safety profile of the legally marketed predicate device.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

December 15, 2021

Medtronic, Inc. Laura Hanson Regulatory Affairs Specialist 2300 Berkshire Lane North, Suite 5 Plymouth, Minnesota 55441

Re: K213631

Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: November 15, 2021 Received: November 17, 2021

Dear Laura Hanson:

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 mediation-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,

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K213631

Device Name Chocolate PTA Balloon Catheter

Indications for Use (Describe)

The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.

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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Medtronic

Special 510(k) Summary Chocolate PTA Balloon Catheter

510(k) Summary	This summary is being submitted in accordance with therequirements of 21 CFR § 807.92.
Applicant/ Submitter	Medtronic, Inc.2300 Berkshire Lane North, Suite 5Plymouth, MN 55441Tel: 763-591-3024
Contact Person	Laura HansonRegulatory Affairs SpecialistTel: 763-591-3024Email: laura.r.hanson@medtronic.com
Secondary Contact Person	Brandon Casa de CalvoRegulatory Affairs Senior ManagerTel: 763-591-3024Email: brandon.m.casa.de.calvo@medtronic.com
Date Prepared	November 9, 2021
Device Trade Name	Chocolate PTA Balloon Catheter
Submission 510(k) Number	K213631
Device Common Name	Angioplasty Catheter
Classification Name	Percutaneous catheter, Cardiovascular
Regulation Number	21 CFR 870.1250
Classification	Class II
Classification Panel	Cardiovascular
Product Code	LIT
Primary Predicate Device	Chocolate PTA Balloon Catheter
Primary Predicate 510(k)Number	K130414
Primary PredicateRegulation Number	21 CFR 870.1250
Indications for Use	The Chocolate PTA balloon catheter is intended for balloondilatation of lesions in the peripheral vasculature, including theiliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
Device Description	The Chocolate PTA Balloon Catheter is an "over-the-wire" balloondilatation catheter with a braided shaft and an atraumatic tapered tip.The product family consists of 0.014" and 0.018" systems that arecompatible with 0.014" and 0.018" guidewires, respectively. Overallcatheter lengths range from 120-150 cm.
	The distal end of the catheter has a semi-compliant balloon thatexpands to known diameters at specific pressures. The balloon isconstrained by a nitinol constraining structure (CS) which providesfast deflation and uniform re-wrap. Upon deflation, the CS is removedfrom the vessel along with the balloon catheter. The balloon isavailable in multiple sizes and contains two radiopaque markers toassist with positioning. The proximal end of the device is a commonballoon catheter design of a braided shaft connected to a plastic huband strain relief. The hub has two ports; the balloon port is used toinflate the balloon and the guidewire port connects to the guidewirelumen.
	The Chocolate PTA balloon catheter is intended for single-use onlyand is provided sterile and non-pyrogenic.
Comparison ofTechnologicalCharacteristics	The subject Chocolate PTA Balloon Catheter components will haveminor changes to the materials used which are equivalent to thematerials used in the predicate device. These material changes arebeing implemented alongside supplier changes to ensure a more robustsupply chain.Additionally, in order to support EU MDR requirements, Chocolate'sIFU is being changed in size and stitching to accommodate additionalglobal language requirements with a change to eliminate renal arteriesfrom the indications for use.The subject Chocolate device shares the following technologicalcharacteristics with the predicate device. These characteristics areconsidered identical between the subject and predicate.
	● Intended Use
	● Principle of Operation
	● Balloon technical specifications including availablediameters, lengths, materials, radiopaque markers, rated burstpressure, nominal pressure and constraining structure material
	● Catheter technical specifications including available lengths,guidewire compatibility, introducer compatibility, and allmaterials except for the inner member component materialslisted in Table 7.1.
	● Packaging materials
	● Testing and Compliance to ISO 10993 and ISO 11135-1
Table 7.1: Chocolate PTA Balloon Catheter Predicate to Subject Equivalencies

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● Sterilization Method

Table 7.1 below outlines the characteristics between the predicate and subject Chocolate PTA Balloon Catheters that are not identical but are considered similar and equivalent.

	Predicate Device	Subject Device
Device Name	Chocolate PTA Balloon Catheter(Primary Predicate)	Chocolate PTA Balloon Catheter
Indications forUse	The Chocolate®* PTA BalloonCatheter is intended for balloondilatation of lesions in the peripheralvasculature, including the iliac,femoral, ilio-femoral, popliteal,infra-popliteal, and renal arteries.	The Chocolate™* PTA ballooncatheter is intended for balloondilatation of lesions in the peripheralvasculature, including the iliac,femoral, ilio-femoral, popliteal, andinfra-popliteal arteries.
Inner Membercomponent - outerlayer resin	Resin ChangeInner Member materials:Outer layer NY-L25 Grilamid (GrilamidL25 natural) Colorant 833125 Transblue FDA Inner layer PE-LR734 HDPE LR7340-01Petrothene High Density Intermediate layer (tie-layer)PE-Orevac 18300	Resin ChangeInner Member materials:Outer layer NY-L25 Grilamid (Grilamid L25natural) Inner layer PE-LR734 HDPE LR7340-02Petrothene High Density Intermediate layer (tie-layer)PE-Orevac 18300M
IFU(specifications)	Folded & stapled8.5" x 11.0"	Saddle stitch booklet10" x 10"
Compliance Card	5.0" x 6.0"	4.0" x 5.0"Artwork Update
Pouch Label(dimensions)	6.25" x 8.5"	6.38" x 8.00"
Carton Label(dimensions)	6.25" x 10.40"	6.61" x 8.75"

Performance data Due to the physical differences between the subject device IFU and predicate device IFU, the subject Chocolate PTA Balloon Catheter underwent packaging validation, packaging aging, and sterilization testing with a 72-page IFU and eIFU leaflet to resemble worst-case packaging configuration. This 72-page test IFU and eIFU leaflet exceeds the size of the IFU and eIFU leaflet in the subject device. All units passed their respective testing requirements and no additional risks resulted from the changes to the IFU. Medtronic is also performing 3year real-time aging tests to confirm the accelerated aging results. See

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Section 16, Table 16.2 for a summary of completed testing for the subject Chocolate PTA Balloon Catheter IFU changes.

The proposed changes in this submission do not require a change in the sterilization process or equipment (sterilization assurance level: 10-6). Due to successfully completing the testing described in section 15.3.8, it was determined that no sterilization process changes are required due to the proposed changes.

To support the safety and performance of the subject Chocolate PTA Balloon Catheter device, new biocompatibility testing was completed in report D00557778. Biocompatibility Evaluation Report for Chocolate PTA Balloon Catheter for Supplier and Material Changes. The subject Chocolate PTA Balloon Catheter was subjected to the following biocompatibility testing:

Cytotoxicity ●
Sensitization ●
Irritation/intracutaneous reactivity
Acute systemic toxicity
Material mediated pyrogenicity
o Hemocompatibility testing

Based on the biocompatibility data gathered, it was concluded that the subject Chocolate PTA balloon catheter, as guided by ISO 10993-1:2018, passed the required tests and does not present a patient health hazard. As a result of this testing and the associated risk analysis, it was determined that there are no new or increased biocompatibility concerns.

The technological characteristics and performance criteria of the Chocolate PTA Balloon Catheter are equivalent to the predicate device, and the subject device performs in a manner equivalent to the predicate device currently on the market.

Based on the intended use, technological characteristics, device design, Conclusion operating principle, shelf-life testing, packaging validation and sterilization testing. Medtronic concludes the subject Chocolate PTA Balloon Catheter to be substantially equivalent to the predicate Chocolate PTA Balloon Catheter, K130414.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).