(210 days)
Not Found
No
The device is a simple mechanical luer lock plug and the summary contains no mention of AI, ML, or any related concepts.
No.
The device is a luer lock plug for capping hemodialysis catheters, which is an accessory used for the catheter rather than a device with a direct therapeutic effect on the body.
No
The device is a luer lock plug for capping catheters, used for sealing rather than collecting or analyzing information about a patient's health condition. Its description and performance studies focus on physical and biocompatibility testing, not diagnostic capabilities.
No
The device description clearly states it is a "non-vented plastic cap with a male luer," indicating it is a physical hardware component. The performance studies also focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Luer lock plug for capping male or female luer tapers for hemodialysis catheters." This describes a physical accessory used with a medical device (hemodialysis catheter) to maintain sterility and prevent leakage.
- Device Description: The description details a "non-vented plastic cap with a male luer" that connects to a catheter. This is a mechanical component.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description and intended use of this luer lock plug do not involve any testing of biological samples.
- Performance Studies: The performance studies focus on the physical and biocompatibility properties of the cap (leakage, strength, toxicity), not on the accuracy or performance of a diagnostic test.
Therefore, this device is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Luer lock plug for capping male or female luer tapers for hemodialysis catheters.
Product codes
MSD
Device Description
The Medcomp® End cap is non-vented plastic cap with a male luer. The end of the Medcomp® End cap connects directly to the female luer of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench/Performance Data/Non-Clinical Testing was conducted based on the following standards: ISO 594-1:1986 "Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements" and ISO 594-2:1998 "Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings". Performance testing included Gauging, Liquid Leakage, Air Leakage, Stress Cracking, Separation Force, Unscrewing Torque, Ease of Assembly, and Resistance to Overriding.
Biocompatibility evaluation was conducted in accordance with the FDA guidance document: Use of International 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 (
§ 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.
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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
1
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
2
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 Drive | |||
| Harleysville, PA 19438 USA | |||
| Tel (215) 256-4201 | |||
| Fax (215) 256-9191 | |||
| Registration Number: | 2518902 | ||
| Contact Person: | Patrick McDonald | ||
| Senior 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
4
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 Device
End Cap | Predicate Device
The Red Cap
(K820454) |
|----------------------|----------------------------------------------------------|----------------------------------------------------------|
| Prescription | Prescription Use | Prescription Use |
| Intended Use | Luer lock plug for capping
male or female luer tapers | Luer lock plug for capping
male 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 | Performance
Testing |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 594-1:1986 | Conical fittings
with a 6 % (Luer)
taper for syringes,
needles and
certain other
medical
equipment — Part
1: General
requirements | 1986 | Gauging, Liquid
Leakage, Air
Leakage, Stress
Cracking |
| ISO 594-2:1998 | Conical fittings
with 6 % (Luer)
taper for syringes,
needles and
certain other
medical
equipment — Part
2: Lock fittings | 1998 | Separation Force,
Liquid Leakage, Air
Leakage,
Separation Force,
Unscrewing
Torque, Ease of
Assembly,
Resistance to
Overriding, Stress
Cracking |
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
5
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 (