The Caterpillar and Caterpillar Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The Caterpillar Micro Arterial Embolization Devices are contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.

Device Description

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are self-expanding arterial occlusion plugs. The devices consist of the following components and are intended to be a permanent implant: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker bands, and a polyurethane and polyethylene occlusion membrane.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device Systems are packaged as a single unit with the implant, loader, dispenser hoop, detachable delivery wire, and torque tool. The Caterpillar™M Micro delivery wire is coated with a hydrophilic coating. While the Caterpillar™ delivery wire has a PTFE hydrophobic coating. The system is provided sterile and non-pyrogenic and is intended for single use only.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device is designed for a specific arterial diameter range. The artery diameter range and required delivery catheter (ID)) for deployment are provided in the table below.

Product Name	ProductReference	Target ArteryDiameter (mm)	Delivery CatheterCompatibility: InnerDiameter (in/mm)	Marker toMarkerLength(mm)1	MaximumDeployedLength(mm)2	DeliveryWireLength(cm)
Caterpillar™Micro	027	1.5 - 4	0.027 / 0.686	7	16	170
Caterpillar™	038	3 - 6	0.038 / 0.965	17	26	155
Caterpillar™	056	5 - 7	0.056/ 1.422	18	37	155

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices). This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy through a clinical trial with specific performance metrics against a defined acceptance criterion. The "acceptance criteria" referred to in the document are primarily related to general design verification and safety testing, not specific clinical performance endpoints in the way you might find for an AI algorithm.

Therefore, the answers below will reflect the nature of this type of regulatory submission. There is no information provided in this document regarding AI algorithms, human-in-the-loop performance, or AI-specific ground truth methodologies.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific numerical acceptance criteria with corresponding performance values for clinical efficacy. Instead, it lists types of tests performed and states that the device "met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs." The animal study concluded that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints."

Here's an interpretation based on the provided information, focusing on categories of testing:

Acceptance Criteria Category	Reported Device Performance
Physical & Mechanical Properties:	"Met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs" for:
- Dimensions (Implant Length, Catheter Compatibility, Delivery Wire Length and OD)	- Measured values were within specified tolerances.
- Radial Force	- Device exhibited sufficient radial force for its intended function.
- Luer Connection Testing	- Connections met established integrity standards.
- Radiopacity	- Device was adequately visible under fluoroscopy.
- Fatigue Resistance (Pulsatile and Pinching)	- Device maintained integrity and function under simulated physiological stresses.
Simulated Use & Delivery System Performance:	"Met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs" for:
- Visual Inspection	- All components were free from defects.
- Delivery, Load, Track, and Deployment Forces	- Forces required were within clinically acceptable ranges.
- Accuracy of Deployment	- Device deployed accurately to the target site.
- Detachment Time and Mechanism Reliability	- Detachment occurred reliably and within target timeframes.
- Tensile and Torsional Strength	- System demonstrated sufficient strength during use.
- Recapture and Resheathing for Removal	- Device could be recaptured and resheathed if necessary.
- Delivery System Removal (withdrawal)	- System could be safely withdrawn after deployment.
Material Safety & Biocompatibility:	"Met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs" for:
- Corrosion Resistance	- Materials demonstrated adequate corrosion resistance.
- Nickel Leaching	- Nickel leaching was below toxicological thresholds.
- Particulate	- Particulate generation was within acceptable limits.
- MRI Compatibility and Safety	- Device was demonstrated to be safe and compatible with MRI.
- Packaging Testing	- Packaging maintained sterility and protected the device.
- Biocompatibility (ISO 10993)	- Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, genotoxicity, hemolysis, and complement activation tests passed. - Chronic ovine study also addressed subchronic toxicity, implantation, chronic toxicity, and in vivo thrombogenicity. - Chemical characterization testing and toxicological assessment evaluated genotoxicity, chronic toxicity, and carcinogenicity.
In Vivo Performance (Animal Study):	A chronic ovine study found that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints," which included: - Migration resistance - Ease of delivery - Occlusion efficiency - Recanalization - Deliverability - Hemostasis after procedure - Thrombogenicity - Device safety - Freedom from complications

Regarding aspects typically related to AI performance, the document does not contain information on the following:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No "test set" in the context of an AI algorithm. Performance data was generated through various bench tests and one pre-clinical animal study.
Animal Study Sample Size: Not explicitly stated, but implies multiple animals to evaluate chronic effects and comparisons.
Data Provenance: Non-clinical (bench) and pre-clinical (animal) studies. No human data (clinical data) is mentioned as a "test set" for performance evaluation in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable for this type of device submission. "Ground truth" in the context of an AI algorithm is not relevant here. For the animal study, evaluations would typically be done by veterinary specialists, pathologists, and dedicated study personnel according to a protocol.

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

Not applicable for this type of device submission. This is relevant for AI image review. For the animal study, endpoints would be assessed according to pre-defined criteria, likely by the study investigators and possibly independently reviewed by a pathologist for tissue samples.

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

No MRMC study was done, as this is not an AI device. This section is entirely irrelevant to the provided document.

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

Not applicable, as this is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for an AI device. For the non-clinical and pre-clinical animal studies, "ground truth" would be established by:
- Bench Testing: Engineering measurements, adherence to specifications, validated test methods.
- Animal Study: Direct observation by study personnel, pathology findings following necropsy, physiological measurements, imaging results, and histological analysis.

8. The sample size for the training set

Not applicable, as this is not an AI device. No training set exists.

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

Not applicable, as this is not an AI device. No training set exists.

Summary

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

February 4, 2020

ClearStream Technologies Ltd. Melanie Hadlock Regulatory Affairs Specialist II Moyne Upper Enniscorthy, Co. Wexford, Ireland

Re: K191532

Trade/Device Name: Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device

Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: December 30, 2019 Received: December 31, 2019

Dear Melanie Hadlock:

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

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

Page 685

вн

510(k) Number (if known) K191532

Device Name

Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices

Indications for Use (Describe)

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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Caterpillar™ and Caterpillar TM Micro Arterial Embolization Device 510(k) Summary

21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

Submitter Information:

ClearStream Technologies Ltd Moyne Upper, Enniscorthy, Co. Wexford, Ireland Tel: 800.321.4254 480.894.9515 Fax: 480.966-7062 Contact Person: Melanie Hadlock, Senior Regulatory Specialist

Date of Submission: June 7, 2019

Subject Device:

Device Trade Name:	Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device
Common or Usual Name:	Device, Vascular, for Promoting Embolization
Classification:	Class II
Classification Name:	Vascular Embolization Device, KRD
Review Panel:	Cardiovascular
Regulation Number:	21 CFR 870.3300

Predicate Device:

Device Trade Name:	Amplatzer™ Vascular Plug II (AVP II)
Common or Usual Name:	Device, Vascular, for Promoting Embolization
Classification:	Class II
Classification Name:	Vascular Embolization Device, KRD
Review Panel:	Cardiovascular
Regulation Number:	21 CFR 870.3300
510(k) Numbers:	K071699, cleared August 15, 2007

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Reference Device:

Device Trade Name:	Amplatzer™ Vascular Plug 4 (AVP4)
Common or Usual Name:	Device, Vascular, for Promoting Embolization
Classification:	Class II
Classification Name:	Vascular Embolization Device, KRD
Review Panel:	Cardiovascular
Regulation Number:	21 CFR 870.3300
510(k) Number:	K113658, cleared June 12, 2012

Device Description:

Product Name	ProductReference	Target ArteryDiameter (mm)	Delivery CatheterCompatibility: InnerDiameter (in/mm)	Marker toMarkerLength(mm)1	MaximumDeployedLength(mm)2	DeliveryWireLength(cm)
Caterpillar™Micro	027	1.5 - 4	0.027 / 0.686	7	16	170
Caterpillar™	038	3 - 6	0.038 / 0.965	17	26	155
Caterpillar™	056	5 - 7	0.056/ 1.422	18	37	155

The Marker to Marker Length is the distal radiopaque marker band to the most proximal radiopaque marker 1. band.

The Maximum Deployed Length is the length from the distal fibers in the minimum target artery diameter.

Indications for Use:

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The devices are contraindicated for use in vessels subject to cyclic bending, such as locomotive joints or muscle beds.

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K191532 Page 3 of 4

Comparison to Predicate device:

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device have the following similarities to the predicate device, the Amplazter™ Vascular Plug II, AVP II (K071699, cleared August 15, 2007):

Same intended use
. Similar target population
Similar technological characteristics
Similar user interface
Same mechanism of action
Same sterility assurance level and method of sterilization ●
Similar materials ●

The reference device Amplazter™ Vascular Plug 4. AVP4 (K113658, cleared June 12, 2012) has the above similarities and was used to support the methods used for characterization of delivery system performance based on similarities of the delivery system.

The subject devices, the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device, have the following changes:

Contraindication ●
A new implant design
A modified delivery system ●

Performance Data:

To demonstrate substantial equivalence of the subject device to the predicate devices, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices, consensus standards, and internal risk assessment procedures, the following tests were performed on the subject device:

. Dimension
- Implant Length o
- O Catheter Compatibility
- O Delivery Wire Length and Outer Diameter
Radial Force ●
Luer Connection Testing ●
Radiopacity ●
Simulated Use
- Visual Inspection o
- Delivery, Load, Track and Deployment Forces O
- Accuracy of Deployment O
- Detachment Time and Detachment Mechanism Reliability o
- Tensile and Torsional Strength o
- Recapture and Resheathing for Removal o
Delivery System Removal (withdrawal) ●
Fatigue Resistance
- Pulsatile and Pinching Compression O
. Material Safety Testing
- Corrosion Resistance O

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Nickel Leaching o
Particulate O
MRI Compatibility and Safety ●
Packaging Testing .
Biocompatibility per ISO 10993 ●
- Cytotoxicity, sensitization (guinea pig maximization test), intracutaneous reactivity, acute o systemic toxicity, material-mediated pyrogenicity, genotoxicity (in vitro bacterial reverse mutation assay and in vitro mouse lymphoma assay), hemolysis (direct and indirect), and complement activation.
- Biocompatibility endpoints for subchronic toxicity, implantation, chronic toxicity, and in vivo O thrombogenicity were addressed within the chronic ovine animal study.
- Biocompatibility endpoints for genotoxicity, chronic toxicity, and carcinogenicity were evaluated O with chemical characterization testing and toxicological assessment

Pre-Clinical Animal Study:

A chronic ovine study was performed to evaluate the chronic safety and performance of the Caterpillar and Caterpillar Micro Arterial Embolization Devices. The animal study included evaluations for migration resistance, ease of delivery, occlusion efficiency, recanalization, deliverability, hemostasis after procedure, thrombogenicity, device safety, and freedom from complications for the study. The results demonstrated that the study device performance was equivalent or superior to control devices across each of the evaluated endpoints.

Conclusions:

The subject devices, the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device, met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs. The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device are substantially equivalent to the legally marketed predicate device, the Amplatzer™ Vascular Plug II, AVP II (K071699, cleared August 15, 2007) and the reference device Amplatzer™ Vascular Plug 4, AVP 4 (K113658, cleared June 12, 2012).

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).