The provided document is a 510(k) summary for a medical device called "End Cap". It details the device's description, indications for use, comparison to a predicate device, and performance data for demonstrating substantial equivalence.

However, the questions you've asked are specifically about the acceptance criteria and study proving the device meets acceptance criteria for an AI/ML-enabled medical device. The provided document is for a physical medical device (luer lock plug) and does not involve AI or machine learning. Therefore, the questions related to AI/ML device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.

The document discusses performance testing (bench testing) to ensure the physical device meets relevant standards, but this is different from the type of performance evaluation required for an AI/ML diagnostic or predictive device.

Here's how I can address the applicable parts of your request based on the provided document, interpreting "acceptance criteria" in the context of a physical device's regulatory submission:

The "acceptance criteria" for this device's submission revolves around demonstrating substantial equivalence to a legally marketed predicate device by meeting recognized consensual standards for physical device performance and biocompatibility.

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

For a physical device like the End Cap, acceptance criteria are typically defined by compliance with recognized international standards (ISO standards in this case) and demonstrating safe and effective performance. The "reported device performance" is essentially that the device passed these tests, confirming its compliance.

Acceptance Criteria (Defined by Standard)	Reported Device Performance (as stated in submission)
ISO 594-1:1986	Passed (Medcomp® End Cap met requirements for Gauging, Liquid Leakage, Air Leakage, Stress Cracking)
* Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
ISO 594-2:1998	Passed (Medcomp® End Cap met requirements for Separation Force, Liquid Leakage, Air Leakage, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking)
* Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process	Passed (Met biocompatibility requirements for an external communicating device with circulating blood contact for a limited duration (<24 hours), including tests for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, and Acute Systemic Toxicity)

Important Note: The document states that the testing was performed and the device "met" the requirements. It doesn't provide specific numerical results or raw data for these tests, as is typical for a 510(k) summary (which summarizes the full testing report).

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

Sample Size: Not explicitly stated for each test, but typically these tests involve a specific number of units of the device as defined by the standards themselves or internal quality protocols.
Data Provenance: The testing was "Bench/Performance Data/Non-Clinical Testing" and "Biocompatibility evaluation." This implies laboratory testing performed by or for the manufacturer (Medcomp®, located in Harleysville, PA, USA). This is prospective testing, as it's specifically conducted to support the regulatory submission.

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 a physical device, "ground truth" is established by adherence to engineering specifications and international standards, measured by calibrated equipment and qualified lab personnel, not clinical experts interpreting images or diagnostic data.

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

Not applicable. This is for AI/ML model output, not physical device performance testing.

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

Not applicable. This device is not an AI/ML diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm.

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

For this physical device, the "ground truth" is adherence to the specifications outlined in the ISO standards, which define acceptable functional performance (e.g., specific force required, leak rate, biocompatibility). Compliance is measured mechanically or chemically, not via clinical or expert assessment of "truth" in a diagnostic sense.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model.

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

Not applicable. This is a physical device, not an AI/ML model.

In summary, the provided document pertains to a traditional physical medical device and therefore the acceptance criteria and study methods are fundamentally different from those for an AI/ML-enabled device. The "study" proving the device meets acceptance criteria is the successful completion of the specified bench testing and biocompatibility assessments in accordance with recognized standards, demonstrating the device's substantial equivalence to its predicate.

Summary

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September 14, 2021

Medical Components Inc. (Medcomp®) Patrick McDonald Regulatory Affairs Manager, North America and Europe 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K210461 Trade/Device Name: End Cap Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MSD Dated: August 9, 2021 Received: August 16, 2021

Dear Patrick McDonald:

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

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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 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 (OS) 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 Glenn B. Bell, Ph.D. Director THT3A1: Renal, Gastrointestinal, Obesity and Transplantation Devices 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) K210461

Device Name End Cap

Indications for Use (Describe)

Luer lock plug for capping male or female luer tapers for hemodialysis catheters.

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)

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ville. PA 19438. L 15 256 420 F: 215 256.1787 medcompnet.com

Medcomp®: End Cap

Section 6		510(k) SUMMARY	Traditional 510K
A. Submitter Information
Submitter Name:	Medical Components Inc.(dba Medcomp ®)1499 Delp DriveHarleysville, PA 19438 USATel (215) 256-4201Fax (215) 256-9191
Registration Number:	2518902
Contact Person:	Patrick McDonaldSenior Regulatory Affairs Manager,North America and EU
Date of Preparation:	06AUG2021
B. Subject Device
Trade Name:	End Cap	Device:	Catheter, Hemodialysis, Implanted
Regulation Description:	Blood access device and accessories
Product Code:	MSD	Regulation Number:	876.5540
Class:	2	Review Panel:	Gastroenterology/Urology
C. Predicate Device
Predicate Trade Name:	The Red Cap	510(k) Number:	K820454
510(k) Applicant:	Burron Medical Products, Inc.	Device:	Syringe, Piston
Regulation Description:	Piston Syringe
Product Code:	FMF	Regulation Number:	880.5860
Class:	II	Review Panel:	General Hospital
D. Device Description:
The Medcomp® End cap is non-vented plastic cap with a male luer. The end o

E. Indications For Use:

connects directly to the female luer of the catheter.

Medcomp®: End Cap Section 6: 510(k) Site Summary 6-1

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Luer lock plug for capping male or female luer tapers for hemodialysis catheters.

F. Intended Use:

Luer lock plug for capping male or female luer tapers

G. Comparison to Predicate Device:

Table 6.1: 510(k) Summary Design Comparison Matrix

Attribute	Subject DeviceEnd Cap	Predicate DeviceThe Red Cap(K820454)
Prescription	Prescription Use	Prescription Use
Intended Use	Luer lock plug for cappingmale or female luer tapers	Luer lock plug for cappingmale or female luer tapers
Duration of Use	Short Term Use	Legally Marketed
Sterilization Method	EO	EO

H. Bench/Performance Data/Non-Clinical Testing:

Table 5.2: Applicable Standards and Performance Testing

Standard	Standard Title	Revision/Date	PerformanceTesting
ISO 594-1:1986	Conical fittingswith a 6 % (Luer)taper for syringes,needles andcertain othermedicalequipment — Part1: Generalrequirements	1986	Gauging, LiquidLeakage, AirLeakage, StressCracking
ISO 594-2:1998	Conical fittingswith 6 % (Luer)taper for syringes,needles andcertain othermedicalequipment — Part2: Lock fittings	1998	Separation Force,Liquid Leakage, AirLeakage,Separation Force,UnscrewingTorque, Ease ofAssembly,Resistance toOverriding, StressCracking

I. Biocompatibility

The biocompatibility evaluation for the End Cap was conducted in accordance with the FDA guidance document: Use of International

Medcomp®: End Cap Section 6: 510(k) Site Summary

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Medcomp®: End Cap

Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" and International Standard ISO 10993-1 "Biocompatibility Evaluation of Medical Devices - Part 1 Evaluation and Testing Within a Risk Management Process", as recognized by the FDA. The End Cap met the biocompatibility requirements for an external communicating device with circulating blood contact for a limited (<24 hours) duration. The biological endpoints that were met as are follows:

CYTOTOXICITY

Vitro Cytotoxicity

SENSITIZATION

ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for o Irritation and Skin Sensitization

IRRITATION OR INTRACUTANEOUS REACTIVITY

ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for 0 Irritation and Skin Sensitization

ACUTE SYSTEMIC TOXICITY

ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for o Systemic Toxicity

J. Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing. the subject device, End Cap, raises no new questions of effectiveness compared to the predicate device and is substantially equivalent to the predicate device, The Red Cap (K820454).

Regulation Number and Section

§ 876.5540 Blood access device and accessories.

(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.