The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

Device Description

The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm. The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™. The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.

AI/ML Overview

The provided document (K032061) describes a 510(k) premarket notification for a medical device, specifically a 15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria in the context of an AI/human performance study.

Therefore, much of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment cannot be found in this document because the document describes a traditional medical device (a catheter) and not an AI/ML-driven device.

However, I can extract the information related to the device's performance based on the provided text.

Here's an attempt to answer the questions based only on the provided text, noting where information is unavailable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by comparison to predicate devices and/or conformance to established ISO standards for hemodialysis catheters. The document states the device met these criteria. Specific numerical values for criteria are not detailed in this summary.

Performance Metric Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Results of selected biocompatibility testing for the catheter and carbothane resin. (Criteria implicitly met if documented in Appendix B, which is not provided).	"Selected biocompatibility testing was conducted on the catheter and carbothane resin. Results are provided in Appendix B." (Assumed to meet criteria).
Flow Rates	Similar product performance flow rates as predicate devices (Spire Biomedical, Inc.'s Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips).	"15.5Fr Decathlon catheters have similar product performance flow rates as compared to our silicone Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips."
Priming Volumes	Similar priming volumes as predicate devices (Spire Biomedical, Inc.'s Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips).	"15.5Fr Decathlon catheters have similar product performance... priming volumes as compared to our silicone Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips."
Mechanical & Physical Tests	Equivalent to predicate devices (Spire Biomedical, Inc.'s Pourchez XpressO™, MedComp Ash Split Cath™, Kendall Healthcare Maxid™) or conformation to established ISO standards for hemodialysis catheters. Exceed minimum acceptance criteria established by appropriate standard.	"A series of mechanical and physical tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the 15.5Fr "Decathlon" catheter demonstrated equivalent or better performance to the predicate devices and/or exceeded the minimum acceptance criteria established by the appropriate standard."
Material Composition	Identical polyurethane material to Kendall Healthcare Maxid™ catheter.	"The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix G)."
Luer Adapters	Qualified for optional use of polyvinyl chloride luer adapters.	"Optional use of polyvinyl chloride luer adapters has also been qualified."

2. Sample size used for the test set and the data provenance

This document describes a physical medical device (catheter), not an AI algorithm. Therefore, the concept of a "test set" in the context of AI performance data (e.g., images for classification, clinical data for prediction) does not apply here. The document describes tests performed on the physical catheter rather than a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is for a physical medical device, not an AI algorithm requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This is for a physical medical device, not an AI algorithm with a test set requiring adjudication.

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 document pertains to a physical medical device. It does not involve AI or human readers.

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

Not applicable. This document pertains to a physical medical device, not an AI algorithm.

7. The type of ground truth used

For the performance data described, the "ground truth" is established through:

Comparison to predicate devices: Performance characteristics (flow rates, priming volumes) were deemed acceptable if they were "similar" to the legally marketed predicate devices.
Conformance to established ISO standards: Mechanical and physical tests were evaluated against relevant ISO standards for hemodialysis catheters.
Analytical verification: Material composition was verified through an "IR Scan analysis."

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI algorithm with a training set.

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

Not applicable. This document is for a physical medical device, not an AI algorithm.

Summary

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K03206/

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Image /page/0/Picture/2 description: The image shows the logo for Spire Biomedical. The word "spire" is in bold, black, sans-serif font. Above the "i" in "spire" is a black circle with spikes coming out of it. Below "spire" is the word "Biomedical" in a cursive font.

DEC 2 3 2003

Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax

SECTION 7

510(K) SUMMARY

15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter

Date: July 2, 2003

Submitter: Spire Biomedical, Inc. One Patriots Park Bedford, MA 01730-2396 Phone: (781) 275-6001 Fax: (781) 275-6010

Contact Person: Donald Fickett Director of RA/QA Spire Biomedical, Inc. Phone: (781) 275-6001 x221 Fax: (781) 275-6010 e-mail: dfickett@spirecorp.com

Device Names:

Trade Name:	15.5Fr “Decathlon” Twin Lumen Chronic Hemodialysis Catheters
Common Name:	Catheter, Intravascular, Long-Term
Classification Name:	Catheter, Hemodialysis, Implant (Long-Term)

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

1. Spire Biomedical, Inc.'s Pourchez XpressO™ (Split tip distal end, twin lumen proximal end configuration including identical component clamps, luer adapters, product performance and same indication for use)
1. Medical Components, Inc. Ash Split Cath™ (round outer profile with semi-circular cross-sectional lumens)
1. Kendall Healthcare Maxid™ (same polyurethane material for catheter body, hub and tubing)

Device Description: The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm.

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KC32061

Page 2 of 2

Image /page/1/Picture/2 description: The image shows the logo for Spire Biomedical. The logo consists of the word "spire" in a bold, sans-serif font, with the word "Biomedical" in a smaller, cursive font underneath. Above the word "spire" is a symbol that resembles a sun or starburst, with multiple rays or points emanating from a central circle. The entire logo is in black and white.

Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax

510(K) Summary (Continued)

15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter

Intended Use: The indications for use of the 15.5Fr "Decathlon" catheters are identical to the Pourchez XpressO™ Twin Lumen Chronic Hemodialysis catheter with Separated Tips. The 15.5Fr "Decathlon" is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion via cutdown into the jugular or subclavian vein.

Technological Characteristics Comparison to Predicate Devices: The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™ The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.

Selected biocompatibility testing was conducted on the catheter and carbothane resin. Results are provided in Appendix B.

Performance Data: 15.5Fr "Decathlon" catheters have similar product performance flow rates and priming volumes as compared to our silicone Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The polyurethane resin is similar to the Kendall Maxid catheter. A series of mechanical and physical tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the 15.5Fr "Decathlon" catheter demonstrated equivalent or better performance to the predicate devices and/or exceeded the minimum acceptance criteria established by the appropriate standard.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

Mr. Donald Fickett Director of RA/QA Spire Biomedical, Inc. One Patriots Park BEDFORD MA 01730-2396

Re: K032061

Trade/Device Name: 15.5Fr Polyurethanc "Decathlon" Twin Lumen Chronic Hemodialysis Catheter; 24cm, 28cm, 32cm, 36cm and 40cm Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: September 29, 2003 Received: October 6, 2003

Dear Mr. Fickett:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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

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Page 2 - Mr. Donald Fickett

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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

David A. Segarm

for

Nancy C. Brogdor Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO32061

Image /page/4/Picture/1 description: The image shows the logo for Spire Biomedical. The logo consists of the word "spire" in a bold, sans-serif font, with the word "Biomedical" in a smaller, cursive font underneath. Above the word "spire" is a symbol that resembles a stylized sun or asterisk with multiple points radiating outward.

Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax

APPENDIX B - Indications for Use Statement

Device Name: 15.5 Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (24cm, 28cm, 32cm, 36cm & 40cm)

The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Indications for Use: Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniela Leggmm

(Optional Format 3-10-98)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number: 032061

Prescription Use

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.