The PerfIC Cath™ is intended for use in adult male patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Device Description

The PerfIC Cath™ is a single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in length, with two (2) oval eyelet holes for intra-bladder urine drainage at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. The product will be available in a straight and Coude tip configuration (also termed a Tiemann tip). Additionally, the PerfiC Cath™ will be offered with either aqueous gel lubricant or hydrophilic coating. The distal end of the catheter is connected to a PVC urine collection bag. The product is available in a 14French only.

AI/ML Overview

This document is a 510(k) premarket notification for the Adapta Medical PerfIC Cath™, a urological catheter. It asserts substantial equivalence to a predicate device. The information provided does not include the type of study typically associated with AI/ML device performance (e.g., diagnostic accuracy, sensitivity, specificity, clinical outcome studies). Instead, the performance data focuses on engineering and material characteristics.

Here’s an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Device Attribute	Acceptance Criteria (Predicate PerfIC Cath™)	Reported Device Performance (Modified PerfIC Cath™)
Intended Use	Intended for bladder drainage in adult male and adult female patients.	Identical
Packaging	Pouched kit containing catheter assembly, gauze sponge, gloves, BD wipe, hook.	Pouched kit containing catheter assembly, benzalkonium disinfectant wipe, and plastic hook; thumb holes to facilitate opening by limited dexterity patients. (Substantially Equivalent, some components like gauze and gloves not explicitly mentioned for the new device as being present, but the overall kit concept is similar).
Labeling	Adhesive-backed label with preprinted information applied to sterilization pouch; Instructions for Use (IFU) supplied separately.	Identical
Protective Cap and Lubricating Tip Assembly	Protective rigid cap with thumb loop over one-piece molded silicone-like lubricant reservoir which retains catheter tip.	Identical
Catheter Body	Straight 14 Fr medium soft catheter tube with rounded, sealed proximal tip with two offset inlet holes; nominally 40 cm length.	Straight and Coude (curved tip) 14 Fr, medium soft catheter tube with rounded, sealed proximal (patient contact) tip with two (2) offset inlet holes on opposite sides of the catheter; catheter length nominally 45 cm. (Substantially Equivalent; Coude tip is new and compared to a different predicate (Bever Medical Tiemann Tip K111405)).
Protective Outer Sheath	Polypropylene with 4% silicone, 0.004" thick; sufficient length to seal.	Low density polyethylene, 0.002" thick; sufficient length to seal. (Substantially Equivalent, material and thickness differ but function is similar).
Urine Collection Bag	900-ml volume, flat 11 cm x 41 cm, pre-attached.	1000-ml volume, flat 11 cm x 43 cm, pre-attached. (Substantially Equivalent, slight volume and dimension difference).
Sterility	Entire package sterilized via electron beam irradiation to SAL 10-6.	Entire package sterilized via ebeam irradiation to Sterility Assurance Level of 10-6. (Identical)
Biocompatibility	Patient contact materials tested according to ISO 10993-1:2009 for Cytotoxicity, Dermal Sensitization, and Irritation (vaginal).	Patient contact materials tested according to ISO 10993-1:2009, including: Cytotoxicity, Dermal Sensitization, and Irritation (vaginal). (Substantially Equivalent)
Lubricant	Aqueous lubricant gel	Aqueous lubricant gel or hydrophilic coating-with-water sachet. (Substantially Equivalent, hydrophilic coating is new).
Catheter Advancement Force	Force to advance catheter through lubricant reservoir ≤ 1.5 newtons (0.33 pounds).	Force to advance catheter through lubricant reservoir ≤ 1.5 newtons (0.33 pounds). (Identical)
Bond Tensile Strength	Sheath to lubricant reservoir & sheath to collection bag inlet bond strength ≥ 2.2 newtons (0.5 pounds).	Identical
Overall Catheter Tensile Strength	Separation/Disassembly tensile strength of flexible reservoir component ≥ 15 newtons (3.37 pounds).	Identical

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

The document describes "Design verification and validation testing of the new versions of the intermittent catheter" involving tests for Mechanical Integrity, Advancement Force, and Biocompatibility. However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). The study appears to be an engineering/laboratory-based testing rather than a clinical study with patients.

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

This information is not provided in the document. The "ground truth" here would relate to the performance of the catheter against engineering specifications, not clinical diagnoses.

4. Adjudication Method for the Test Set:

This information is not provided and is not typically applicable to the type of engineering verification testing described.

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, an MRMC comparative effectiveness study was not done. This device is a urological catheter, not an AI/ML-driven 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:

No, a standalone algorithm performance study was not done. This is a medical device (catheter), not an algorithm or software-only device.

7. The Type of Ground Truth Used:

The "ground truth" or reference standard used here is the established engineering specifications and performance characteristics of the predicate device and relevant international standards (e.g., ISO 10993-1:2009 for biocompatibility). For example, the advancement force acceptance criteria sets the "ground truth" for that specific performance metric.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/ML device that requires a training set. The "training set" would implicitly be relevant prior versions of the device and general engineering knowledge applied to the design.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8. The "ground truth" for the predicate device's performance was established through its initial design verification and validation testing.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2016

Adapta Medical, Inc. % Neil Burris Regulatory Consultant Neil Burris & Associates 4250 Grove Street Denver. CO 80211

Re: K161445 Trade/Device Name: PerfIC Cath Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: July 20, 2016 Received: July 21, 2016

Dear Neil Burris:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) Not Known K161445

Device Name PerfIC Cath

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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FORM FDA 3881 (8/14)

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Section 6: 510(k) Summary

The following information is provided as required by 21 CFR §807.92 for the PerfIC Cath™ Urinary Catheter System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor:

Adapta Medical 142 Talamine Court Colorado Springs, CO 80907

Contact:

Name: Neil Burris Title: Regulatory Consultant – Adapta Medical Phone: 720 323 1662 Fax: 720 746 6390 E-mail: neil@sssnpartners.com

Submission Date: May 24, 2016

Proprietary Name: PerfIC Cath™ Common Name: Urologic Catheter and Accessories Regulation: 21 CFR §876.5130 Regulatory Class: Class II Product Code: EZD Predicate Device(s): Primary - Adapta Medical: PerfIC Cath™ (K103043) Secondary "Reference" Predicate - Hangzhou Bever Medical Device Co., Ltd.: Bever Medical Intermittent Catheters (K111405)

Device Description:

Intended Use:

The PerflC Cath™ is intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

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Summary of the Technological Characteristics Comparison to Predicate Device:

The PerfIC Cath™ has the same intended use and fundamental scientific technology as the predicate device. They are urinary catheters for intermittent use, with flexible insertion tips and lubricated catheter tubes for patient comfort and easy insertion, and with outer sheaths over the catheter per se so that a user can more easily maintain clean technique.

The only differences between the predicate device and the proposed device are the additional offering of curved Coude tip (Tiemann tip) versions, and hydrophilically coated versions as an alternative to aqueous gel lubricant. Versions with hydrophilic coating include a sterile water sachet for activation of the lubricant coating.

Performance Data Summary:

The modified PerflC Cath™ catheters have been tested as required for design verification and validation. Design verification and validation testing of the new versions of the intermittent catheter included the following tests.

Mechanical Integrity Advancement Force Biocompatibility

The product performance test results support substantial equivalence between the predicate PerfIC Cath™ and the modified PerfIC Cath™.

Substantial Equivalence:

The proposed PerfIC Cath™ device line has the same indication for use and fundamental scientific technological characteristics as the predicate device. Based on this, the design and the summary of design control activities provided in this submission, the proposed device has been shown to be substantially equivalent to the PerfIC Cath™ cleared to market under 510(k) K103043. Refer to the table below for a listing of the points compared for substantial equivalence. The modified PerfIC Cath™ devices are all substantially equivalent to the predicate PerfiC Cath™, and the curved Coude tip is substantially equivalent to the Tiemann Tip of the reference predicate, the Bever Intermittent Catheter (K111405).

Continued next page

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Comparison Table Showing Substantial Equivalence between PerfIC Cath™ and predicate PerfIC Cath™

DeviceAttribute	PerfIC Cath™ [Straight andCoude Tip Models with eitherGel or Hydrophilic Coating	PerfIC Cath™ original KitK103043	Equivalent
Intended Use	The PerfIC Cath™ is intended foruse in adult male and adultfemale patients requiring bladderdrainage as determined by theirphysician. This device isindicated for those individualswho are unable to promotenatural urine flow or for thoseindividuals who have a significantvolume of residual urinefollowing a natural bladder-voiding episode.	The PerfIC Cath™ is intendedfor use in adult male and adultfemale patients requiringbladder drainage as determinedby their physician. This device isindicated for those individualswho are unable to promotenatural urine flow or for thoseindividuals who have asignificant volume of residualurine following a naturalbladder-voiding episode.	Identical
Packaging	Pouched kit containing catheterassembly, benzalkoniumdisinfectant wipe, and plastichook; thumb holes to facilitateopening by limited dexteritypatients.	Pouched kit containing catheterassembly, gauze sponge,procedure gloves, andbenzalkonium disinfectant wipe,and plastic hook; thumb holes tofacilitate opening by limiteddexterity patients.	SubstantiallyEquivalent
Labeling	Adhesive-backed label withpreprinted information applied tosterilization pouch; Instructionsfor Use (IFU) supplied separately.	Adhesive-backed label withpreprinted information appliedto sterilization pouch;Instructions for Use (IFU)supplied separately.	Identical
ProtectiveCap andLubricatingTip Assembly	Protective rigid cap with thumbloop over one-piece moldedsilicone-like lubricant reservoirwhich retains catheter tip.	Protective rigid cap with thumbloop over one-piece moldedsilicone-like lubricant reservoirwhich retains catheter tip.	Identical
CatheterBody	Straight and Coude (curved tip)14 Fr, medium soft catheter tubewith rounded, sealed proximal(patient contact) tip with two (2)offset inlet holes on oppositesides of the catheter; catheterlength nominally 45 cm.	Straight 14 Fr medium softcatheter tube with rounded,sealed proximal (patientcontact) tip with two (2) offsetinlet holes on opposite sides ofthe catheter; overall catheterlength nominally 40 cm.	Substantiallyequivalent;Coude tipsubstantiallyequivalent toBeverMedicalTiemann TipK111405
DeviceAttribute	PerfIC Cath™ [Straight andCoude Tip Models with eitherGel or Hydrophilic Coating	PerfIC Cath™ original KitK103043	Equivalent
ProtectiveOuter Sheath	Outer sheath over sterilecatheter body made of lowdensity polyethylene; lengthsufficient to seal betweenreservoir tip and collection bagentrance port effecting retentionof catheter tip at entrance tolubricate reservoir; sheathmaterial nominally 0.002" thick.	Outer sheath over sterilecatheter body made ofpolypropylene with 4% silicone;length sufficient to seal betweenreservoir tip and collection bagentrance port effectingretention of catheter tip atentrance to lubricate reservoir;sheath material nominally0.004" thick.	SubstantiallyEquivalent
UrineCollectionBag	Collection bag pre-attached tocatheter assembly; 1000-mlvolume; flat 11 cm x 43 cm.	Collection bag pre-attached tocatheter assembly; 900-mlvolume; flat 11 cm x 41 cm.	SubstantiallyEquivalent
Sterility	Entire package sterilized viaebeam irradiation to SterilityAssurance Level of 10-6.	Entire package sterilized viaelectron beam irradiation toSterility Assurance Level of 10-6.	Identical
Biocompati-bility	Patient contact materials testedaccording to ISO 10993-1:2009,including: Cytotoxicity, DermalSensitization, and Irritation(vaginal).	Patient contact materials testedaccording to ISO 10993-1:2009,including: Cytotoxicity, DermalSensitization, and Irritation(vaginal).	SubstantiallyEquivalent
Lubricant	Aqueous lubricant gel orhydrophilic coating-with-watersachet	Aqueous lubricant gel	SubstantiallyEquivalent
CatheterAdvancementForce	Force to advance catheterthrough lubricant reservoir ≤ 1.5newtons (0.33 pounds).	Force to advance catheterthrough lubricant reservoir ≤ 1.5newtons (0.33 pounds).	Identical
Bond TensileStrength	Sheath to lubricant reservoir &sheath to collection bag inletbond strength ≥ 2.2 newtons (0.5pounds).	Sheath to lubricant reservoir &sheath to collection bag inletbond strength ≥ 2.2 newtons(0.5 pounds).	Identical
OverallCatheterTensileStrength	Separation/Disassembly tensilestrength of flexible reservoircomponent ≥ 15 newtons (3.37pounds)	Separation/Disassembly tensilestrength of flexible reservoircomponent ≥ 15 newtons (3.37pounds)	Identical

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Conclusions:

The modified PerflC Cath™ devices are substantially equivalent to the predicate PerflC Cath™, and the curved Coude tip is substantially equivalent to the reference predicate, the Bever Medical Intermittent Catheter with a Tiemann Tip.

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.