(106 days)
No
The summary describes a physical repair kit for catheters and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: This device is a repair kit for catheters, designed to replace damaged connectors or extensions. It does not provide any therapeutic effect on its own.
No
The device is described as a repair kit for damaged connectors, clamps, or extension tubing on catheters. Its function is to replace damaged parts, not to diagnose medical conditions or analyze patient data.
No
The device description explicitly states it is a "repair kit" used to replace physical components (luer connectors, clamps, extension tubing) of catheters, and the performance studies involve "physical tests." This indicates a hardware-based device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is used to "replace damaged female luer connectors, clamps, or repair extensions" on specific catheters. This describes a physical repair function on a medical device used in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description reinforces the intended use as a repair kit for catheters.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.
Product codes
78 NFK
Device Description
The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.
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)
A series of physical tests were conducted to demonstrate substantial equivalence to the Pourchez Retro Repair Kit (K022644). Refer to Section 18 "Bench Testing" for physical test data. Biocompatibility testing was conducted only on the new materials. A comparison table for the materials is provided in Section 11.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/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 circular symbol with several points radiating outward, resembling a stylized sun or star. The entire logo is in black and white.
One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 ●FAX 781 275 6010
DEC - 5 2006
SECTION 5 - 510(k) SUMMARY
Repair Kit for XpressO®, Decathion™, and Alta LR™ Catheters
Date: August 15, 2006
- Submitter: Spire Biomedical, Inc. One Patriots Park Bedford, MA 01730-2396 Phone: (781) 275-6000 Fax: (781) 275-6010
- Contact Person: Shekhar Nimkar Director of Product Development & Manufacturing Spire Biomedical, Inc. TEL: (781) 275-6001 x203 FAX: (781) 275-6010 email: snimkar@spirecorp.com
Device Name:
| Trade Name: | Repair Kit for Xpresso®, Decathlon™, & Alta LR™ Catheters |
|---|---|
| Common Name: | Catheter Repair Kit |
| Classification Name: | Repair Kit, Catheter, Hemodialysis |
| Classification: | Class II |
| Device Code: | 78 NFK |
1
K06 2435 4392 -242
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 the word "Biomedical" in a smaller, cursive font underneath. Above the word "spire" is a circular symbol that resembles a sun or a starburst, with multiple points radiating outward from the center.
One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 ·FAX 781 275 6010
DEVICE DESCRIPTION:
The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.
PRODUCT CLAIMS:
Repair kit for damaged female luers, clamps, and extension where there is a minimum of 2.5 cm of viable extension.
TECHNOLOGICAL CHARACTERISTICS COMPARISON TO PREDICATE DEVICES:
The Spire BioMedical repair kit for Xpresso®, Decathlon™, and Alta LR™ catheters is similar to the Pourchez Retro Repair Kit (K022644) in physical characteristics and materials.
PERFORMANCE DATA:
A series of physical tests were conducted to demonstrate substantial equivalence to the Pourchez Retro Repair Kit (K022644). Refer to Section 18 "Bench Testing" for physical test data.
Biocompatibility testing was conducted only on the new materials. A comparison table for the materials is provided in Section 11.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Shekhar D. Nimkar Director of Product Development & Manufacturing Spire Biomedical, Inc. One Patriots Park BEDFORD MA 01730-2396
DEC - 5 2006
Re: K062435
Trade/Device Name: Repair Kit for Xpress0 , Decathlon" , & Alta LR™ Catheters Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NFK Dated: November 28, 2006 Received: November 30, 2006
Dear Mr. Nimkar:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in a bold, stylized font. Underneath the acronym, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The entire logo is surrounded by a dotted circle.
coling and Promoting Public Hoalth
3
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); 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Nancy C. Hogdon
Naney C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 -
4
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, italicized script font underneath. Above the word "spire" is a circular symbol that resembles a stylized sun or flower with multiple petals or rays.
One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 •FAX 781 275 6010
SECTION 4 - INDICATIONS FOR INTENDED USE
510(k) Number:
62435
Device Name: Repair Kit for Xpresso®, Decathlon™, & Alta LRTM Catheters
Indications for Use: To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing.
Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.
Prescription Use
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
andfor
Concurrence of CDRH, Office of Device Evaluation (ODE):
Nancy C Brogdon
(Division Sign Off)
and Radiological De 510(k) Number