(52 days)
No
The summary describes a physical hemodialysis catheter and its mechanical properties, with no mention of software, algorithms, or AI/ML terms.
No.
The device is a hemodialysis catheter, which is used for treatment, but it is not a therapeutic device itself in the sense of directly delivering therapy beyond providing access for hemodialysis. It's a medical device used in a therapeutic procedure.
No
This device is a hemodialysis catheter, designed for delivering and removing blood for treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a physical catheter made of polyurethane, designed for insertion into a vein. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "chronic (long-term) hemodialysis and apheresis." These are procedures performed on the patient's body, not tests performed on samples taken from the body.
- Device Description: The description details a catheter, which is a physical device inserted into the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Using reagents or test kits
This device is a medical device used for therapeutic procedures (hemodialysis and apheresis), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 15.5Fr Alta LR Twin Lumen Fixed Tip Hemodialysis Catheter is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
Product codes
78 MSD
Device Description
The polyurethane 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Decathlon™ radiopaque polyurethane catheters with similar catheter tip-to-hub lengths of 24cm, 28cm, 32cm, 36cm and 40cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular or subclavian vein
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 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 polyurethane 15.5Fr Alta LR fixed tip catheter demonstrated equivalent performance to our Decathlon catheter and exceeds the minimum acceptance criteria established by the appropriate standard.
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/0 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 gear.
Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396
Tel: (781) 275-6001 • (781) 275-6010 fax
APR 1 9 2004
SECTION 7
510(K) SUMMARY
15.5 Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter
| Date: | February 24, 2004 |
|---|---|
| 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 Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis
Catheter |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Catheter, Intravascular, Long-Term |
| Classification Name: | Catheter, Hemodialysis, Implant (Long-Term) |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
- Spire Biomedical, Inc.'s Decathlon ™ (Double--D cross sectional round lumen 1) profile), 510(K) # K032061.
Device Description:
The polyurethane 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Decathlon™ radiopaque polyurethane catheters with similar catheter tip-to-hub lengths of 24cm, 28cm, 32cm, 36cm and 40cm.
1
Image /page/1/Picture/0 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 gear. The entire logo is in black and white.
page 2/2
510(K) Summary (Continued)
15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter
Intended Use: The indications for use of the 15.5Fr Alta LR fixed tip catheters are identical to the Decathlon™ Twin Lumen Chronic Hemodialysis catheter with Separated Tips. The polyurethane 15.5Fr Alta LR is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown into the jugular or subclavian vein.
Technological Characteristics Comparison to Predicate Devices: The 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheters' round lumens with Double-D cross sectional profile is similar to our Decathlon Twin Lumen hemodialysis Catheter with Separated Tips. The catheter design (with the exception of a fixed tip with a bump on the venous lumen) is identical to our polyurethane Decathlon™ catheters listed within our 510(K) Premarket Notification Submission (K032061).
Additionally, 15.5Fr Alta LR Fixed Tip Chronic Hemodialysis catheters have similar product performance flow rates and priming volumes as compared to our Decathlon™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The polyurethane resin and manufacturing processes are identical to Decathlon.
Performance Data: 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 polyurethane 15.5Fr Alta LR fixed tip catheter demonstrated equivalent performance to our Decathlon catheter and exceeds the minimum acceptance criteria established by the appropriate standard.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2004
Donald D. Fickett, Jr., C.Q.E. Director of RA/QA Spire BioMedical, Inc. One Patriots Park BEDFORD MA 01730-2396
Re: K040509
Trade/Device Namc: 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter Models AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Codc: 78 MSD Dated: March 29, 2004 Received: April 5, 2004
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 nrocess (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.
3
Page 2 - Donald Fickett, Jr .
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Toast be devised on 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 (21 CFR Part 807); listing (21 the requirements, motions, more 801); good manufacturing practice requirements as set forth in CI IC First 8075, aboning (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) I mis letter will and w yourse finding of substantial equivalence of your device to a legally premated 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, proced to the marker - 5 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 general micriational 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 yours.
Daniel A. Sgroon
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 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" written in a cursive font underneath. Above the word "spire" is a symbol that resembles a stylized sun or a cluster of cells.
APPENDIX B -- Indications for Use Statement
- 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Device Name: Catheter.
- Indications for Use: The 15.5Fr Alta LR Twin Lumen Fixed Tip Hemodialysis Catheter 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)
David A. Lyonn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number.
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)