The Pourchez XpressO™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

Device Description

The 24cm tip to hub length Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a product line extension of Spire Biomedical, Inc.'s the Pourchez XpressO™ flexible radiopaque silicone catheters. The 24cm catheter supplements the other four tip to hub length catheters (28cm, 32cm, 36cm and 40cm) catheters. The 24cm is also available with and without side holes on the distal ends.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the 24cm Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a standalone study or a multi-reader, multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested items (acceptance criteria, specific reported performance metrics, sample sizes, ground truth details, expert qualifications, adjudication methods, and MRMC study details) are not explicitly present in the provided document.

However, based on the furnished text, here's what can be extracted:

Acceptance Criteria and Device Performance

The document states that the 24cm Pourchez XpressO™ Catheter demonstrated equivalent or superior performance to the predicate devices or exceeded the minimum acceptance criteria established by the appropriate standard.

Acceptance Criteria Category	Reported Device Performance
Overall Performance	Equivalent or superior to predicate devices, or exceeded minimum acceptance criteria established by appropriate standards.
Flow Rates	Similar to the MedComp Ash Split Cath™ (one of the predicate devices).
Priming Volumes	Similar to the MedComp Ash Split Cath™ (one of the predicate devices).
Materials of Construction	Identical to other Pourchez XpressO™ catheters in the initial 510(K) submission (K013160).
Intended Use	Same as predicate devices and initial Pourchez XpressO™ catheters.
Number of Lumens	Same as other Pourchez XpressO™ catheters (Twin Lumen).
Cross-sectional Lumen Area	Similar to other Pourchez XpressO™ catheters.
Insertion Method	Same as other Pourchez XpressO™ catheters (percutaneous via cutdown).
Insertion Sites	Same as other Pourchez XpressO™ catheters (jugular or subclavian vein).

Study Details

Given the nature of a 510(k) summary for a product line extension, the "study" referred to is a series of tests to demonstrate substantial equivalence, rather than a clinical trial with human subjects.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The tests were performed to compare against predicate devices or ISO standards, implying laboratory-based testing rather than clinical data from a specific country. This is likely retrospective in the sense that the predicate device data is pre-existing, and the new device's performance is measured against it.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a device performance test against predicate devices and ISO standards, not a diagnostic or AI-assisted study requiring human expert ground truth.
Adjudication method for the test set:
- Not applicable for a device performance test.
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. This is a medical device (catheter) and not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging product that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, device performance "tests were performed" on the catheter itself, in a standalone manner, to demonstrate its characteristics. However, this is not a software algorithm, but a physical medical device.
The type of ground truth used:
- Predicate Device Performance Data: Performance characteristics of legally marketed predicate devices (Medical Components, Inc. Ash Split Cath™ and MedComp Pourchez XpressO™) served as a benchmark.
- Established ISO Standards for Hemodialysis Catheters: Compliance with these standards formed another part of the "ground truth" or acceptance criteria.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning product requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Köziziz Page lot.

Image /page/0/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, italicized font underneath. Above the word "spire" is a circular graphic that resembles a stylized sun or flower.

Spire Biomedical, Inc. · One Patriots Park · Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-7470 fax

510(K) Summary

24cm Pourchez XpressOTM Twin Lumen Chronic Hemodialysis Catheter with Separated Tips

Date: May 16, 2002

Submitter: Spire Biomedical, Inc. One Patriots Park Bedford, MA 01730-2396 Phone: (781) 275-6000 Fax: (781) 275-7470

Contact Person: Donald Fickett Director of RA/QA Spire Biomedical, Inc. Phone: (781) 275-6000 x221 Fax: (781) 275-7470 e-mail: dfickett@spirecorp.com

Device Names:

24cm Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Trade Name: Catheter with Separated Tips

Catheter, Intravascular, Long-Term Common Name:

Classification Name: Catheter, Hemodialysis, Implant (Long-Term)

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

Medical Components, Inc. Ash Split Cath™ (Flow Performance Characteristics)

1. Mediour Ournportatio, Inc. Pourchez XpressO™ (Performance and Materials Compatibility)
  Device Description: The 24cm tip to hub length Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a product line extension of Spire Biomedical, Inc.'s the Pourchez XpressO™ flexible radiopaque silicone catheters. The 24cm catheter supplements the other four tip to hub length catheters (28cm, 32cm, 36cm and 40cm) catheters. The 24cm is also available with and without side holes on the distal ends.

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K02/2/2 Page 2 of 2

Image /page/1/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 a stylized sun or starburst symbol above the "i". Below "spire" is the word "Biomedical" in a smaller, italicized font. The entire logo is in black and white.

Spire Biomedical, Inc. · One Patriots Park · Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-7470 fax

510(K) Summary (Continued)

24cm Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips

Intended Use: The indicated use and indications of the Pourchez XpressO™ catheter have not changed. It is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion via cutdown into the juqular or subclavian vein.

The 24cm tip to hub length Pourchez XpressO™ Catheter is a product line extension.

Technological Characteristics Comparison to Predicate Devices: The 24cm Pourchez XpressO™ Catheter has the same intended use, same number of lumens, similar cross-sectional lumen area, and the same insertion method and insertion sites as the other tip to hub length Pourchez XpressO™ catheters. The 24cm Pourchez XpressO™ Catheter consists of the identical materials of construction as the Pourchez XpressO™ catheters listed within our initial 510(K) Premarket Notification Submission (K013160).

Additionally, the 24cm Pourchez XpressOTM catheter has similar flow rates and priming volumes as the MedComp Ash Split Cath 1M

Performance Data: A series of tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the 24cm Pourchez XpressO™ catheter demonstrated equivalent or superior performance to the predicate devices or exceeded the minimum acceptance criteria established by the appropriate standard.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2002

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

Re: K021212

Trade/Device Name: 24cm Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and without side holes) Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: April 12, 2002 Received: April 17, 2002

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, 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 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);

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Page 2 - Mr. Donald Fickett

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.

In addition, we have determined that your device kit contains Licocaine 1% which is subject to regulation as a drug.

Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

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 our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act, may be obtained 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/dsma/dsmamain.html

Sincerely yours,

David A. Severson

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

Enclosure

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K021212

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 a stylized sun-like symbol above the "i". Below "spire" is the word "Biomedical" in a smaller, italicized font.

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

APPENDIX A - INDICATIONS FOR USE STATEMENT

The 24cm Pourchez XpressO™ Silicone Twin Lumen Catheter Device Name: with Separated Tips

The Pourchez XpressO™ is a silicone twin lumen catheter with Indications for Use: separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

Prescription Use (Per 21 CFR 801.109)

Emm h. - Begam

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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.