(86 days)
The InfusaSleeve II is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.
The Kaplan-Simpson InfusaSleeve™ II is a multi-lumen catheter consisting of a proximal infusion port, a proximal shaft, and a main catheter shaft which is proximal to the infusion region. An entry port for balloon and guide wire is selected with a distal infusion region. The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equivalent to the proximal infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve II is designed to track over standard dilatation catheters.
This document is a 510(k) premarket notification for the Kaplan-Simpson InfusaSleeve II. It establishes substantial equivalence to a predicate device and does not contain information about a study proving the device meets specific acceptance criteria in the manner described for typical AI/ML medical devices. The document details the device's technical specifications and compares them to a predicate device, along with listing nonclinical tests performed to demonstrate safety and effectiveness.
Therefore, for the requested information about acceptance criteria and a study proving device performance in the context of AI/ML, I must state that this document does not contain that information.
However, I can extract information regarding the nonclinical tests performed and the conclusions drawn from them, which serve as the basis for the device's substantial equivalence determination.
Here's a breakdown of what the document does provide, and what it does not provide, specifically addressing your numbered points:
-
A table of acceptance criteria and the reported device performance:
- No explicit "acceptance criteria" table is provided in the AI/ML sense.
- The document does provide a "COMPARISON OF TECHNOLOGICAL CHARACTERISTICS" table (page 5-6) which compares the new device (InfusaSleeve II) to a predicate device (InfusaSleeve IIa). This comparison implicitly defines the performance characteristics that needed to be equivalent or superior to the predicate for substantial equivalence. The table includes:
- General indications
- Usage (Single use, disposable)
- How supplied (Sterile, non-pyrogenic)
- Sterilization method (100% Ethylene Oxide)
- Materials (Infusion port, Proximal shaft, Main shaft & Tip, Lubricious coating, Radiopaque marker, Hard Stop, Transition marker, Support elements)
- Design & Construction (Catheter configuration, Shaft configuration, Infusion region, Infusion side hole diameter)
- Mode of operation (Solution delivery mode, Maximum proximal infusion pressures)
- Infusion Pressure (psig) vs. Flow Rate (mL/min) data
- Vascular access (Percutaneous)
- Tracking mechanism (Over-the-balloon)
- Size (Total length, Working length, Infusion region length, Outer diameter, Inner diameter)
- Compatibility (Max balloon diameter, Max balloon catheter shaft size, Guiding catheter, Infusion port fitting)
- Radiopacity (via Radiopaque distal markers)
- The "Reported Device Performance" for the InfusaSleeve II is listed in this comparison table. For many characteristics, it is "same" as the predicate. Key numerical differences highlighted include:
- Infusion side hole diameter: 40μm (vs. 28μm for predicate)
- Maximum proximal infusion pressures: 100 psig (vs. 50 psig for predicate)
- Infusion Pressure vs. Flow Rate data for InfusaSleeve II:
- 5 psig: 3 mL/min
- 15 psig: 7 mL/min
- 30 psig: 13 mL/min
- 40 psig: 17 mL/min
- 50 psig: 20 mL/min
- 60 psig: 24 mL/min
- 70 psig: 27 mL/min
- 80 psig: 31 mL/min
- 90 psig: 34 mL/min
- 100 psig: 38 mL/min
- Compatibility: Max balloon diameter 4.0 mm, Max balloon catheter shaft size 3.8 Fr.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This is a traditional medical device submission, not an AI/ML product tested on a data set. The "tests" mentioned are nonclinical (bench and animal) rather than data-driven.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. Ground truth in the AI/ML sense is not relevant for this device.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
-
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/Not provided. This is not an AI/ML device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is not an AI/ML device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this device's performance relies on engineering specifications, material properties, and physical testing outcomes against known standards and the predicate device's performance.
-
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/ML device.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI/ML device.
Information Available on Nonclinical Testing from the Document:
Nonclinical Tests Performed:
- Material biocompatibility
- Bond joint tensile strengths
- Infinite fatigue (likely "infinite duration fatigue" or "endurance limit fatigue")
- Burst pressure
- Flexural properties
- Infusion rates
- Tip expansion resistance
- In vivo animal evaluations
Test Conclusions:
"The test results verified that the InfusaSleeve II performance is equivalent to, or exceeds the predicate InfusaSleeve II device performance."
This indicates that the nonclinical tests were designed to demonstrate that the new device met or surpassed the functional and safety characteristics of its predicate, thereby supporting the claim of substantial equivalence for market approval.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
February 3, 2022
LocalMed, Inc. Aaron Kaplan Chief Science Officer 1820 Embarcadero Rd. Palo Alto, California 94303
Re: K980957
Trade/Device Name: Kaplan-Simpson InfusaSleeve II Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Aaron Kaplan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 10, 1998. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.02.03
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three lines forming its body and head, symbolizing the department's mission to protect the health of all Americans. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
JUN 1 0 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aaron Kaplan, MD Localmed, Inc. 1820 Embarcadero Road Palo Alto, CA 94303
Re: K980957 Kaplan-Simpson Infusasleeve II (100) or IS-2 (100) Trade Name: Regulatory Class: II Product Code: KRA Dated: March 11, 1998 Received: March 16, 1998
Dear Mr. Kaplan:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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. 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Paqe 2 - Dr. Aaron Kaplan
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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, "Misbrandinq by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (K) Number (if known): N/A
Device Name: InfusaSleeve II (IS-2)
Indications for Use:
The InfusaSleeve II is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
్లో ప్ర
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
an (Division Sign-Off)
(Optional Format 1-2-96)
Division of Cardiovascular, Respiratory, and Neurological Devices K40095 510(k) Number
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JUN 10 1998
510(K) SUMMARY
| SUBMITTER'S NAME AND ADDRESS: | LocalMed, Inc.,1820 Embarcadero RoadPalo Alto, CA 94303 |
|---|---|
| PHONE: | (650) 843-6770(650) 843-6771 fax |
| CONTACT PERSON: | Aaron Kaplan, MD |
| DATE SUMMARY PREPARED: | March 11, 1998 |
| DEVICE TRADE NAME: | Kaplan-Simpson InfusaSleeve™ II |
| DEVICE COMMON NAME: | Catheter, infusion |
| DEVICE CLASSIFICATION NAME: | Catheter, continuous flush |
| SUBSTANTIALLY EQUIVALENT DEVICE(S): | InfusaSleeve™ IIa, InfusaSleeve™ II |
DEVICE DESCRIPTION AND FUNCTION:
The Kaplan-Simpson InfusaSleeve™ II is a multi-lumen catheter consisting of a proximal infusion port, a I he 'rapidi-omipon' intesselected with a distal infusion region. An entry port for balloon and guide wire proximal shart, and a main cancer shart which is proximal to the infusion region. See Figure 1.
Image /page/4/Figure/6 description: The image shows a diagram of a medical device, specifically a catheter. The diagram labels different parts of the catheter, including the proximal infusion port, proximal shaft, main catheter shaft, shaft transition marker, balloon/wire entry port, infusion region, radiopaque markers, tip, and flushing tool. There is also a detailed view of the infusion region, showing expansion slits and sideholes.
Figure 1
The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equivalent to the proximal infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve II is designed to track over standard dilatation catheters.
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INTENDED USE:
..............................................................................................................................................................................
The InfusaSleeve II is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urchinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation cather to facilitate selective and subselective access and regional infusion.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
| PREDICATE | ||||
|---|---|---|---|---|
| InfusaSleeve IIa | InfusaSleeve II | InfusaSleeve II | ||
| General indications: | General intravascular use, deliveryof therapeutic solutions. Selectiveand sub-selective controlled infusionof solutions. | same | same | |
| Usage: | Single use, disposable | same | same | |
| How supplied: | Sterile, non-pyrogenic | same | same | |
| Sterilization method: | 100% Ethylene Oxide (EtO)sterilized | same | same | |
| Materials: | ||||
| Infusion port: | Polycarbonate | same | same | |
| Proximal shaft: | Stainless Steel, Nylon | same | same | |
| Main shaft & Tip: | Nylon | same | same | |
| Lubricious coating: | Silicone | same | same | |
| Radiopaque marker: | Gold/Stainless steel | same | same | |
| Hard Stop: | Pellethane | same | same | |
| Transition marker | Stainless steel | - | same | |
| Support elements: | Stainless steel | same | same | |
| Design & Construction: | ||||
| Catheterconfiguration: | Introduced co-axially over adilatation device. Infusion throughperipheral lumens. | same | same | |
| Shaft configuration: | Multi-lumen device. Central lumenaccommodates dilatation device.Four opposing peripheral infusionlumens. | same | same | |
| Infusion region: | Nine-delivery side holes perperipheral lumen. | same | same | |
| Infusion side holediameter: | 28μm | 40μm | 40μm | |
| Mode of operation: | ||||
| Solution deliverymode: | Solution delivery via the peripherallumen side holes into thevasculature. | same | same | |
| Maximum proximalinfusion pressures: | 50 psig | 50 psig | 100 psig | |
| PREDICATE | ||||
| InfusaSleeve IIa | InfusaSleeve II | InfusaSleeve II | ||
| Infusion Pressure (psig) | Flow Rate (mL/min) | |||
| 5 | 5 | 3 | ||
| 15 | 10 | 7 | ||
| 30 | 15 | 13 | ||
| 40 | 17 | 17 | ||
| 50 | 20 | 20 | ||
| 60 | - | 24 | ||
| 70 | - | 27 | ||
| 80 | - | 31 | ||
| 90 | - | 34 | ||
| 100 | - | 38 | ||
| Vascular access: | Percutaneous | same | same | |
| Tracking mechanism: | Over-the-balloon | same | same | |
| Size: | ||||
| Total length: | 1.4 m | same | same | |
| Working length: | 1.3 m | same | same | |
| Infusion region length: | 2 cm | same | same | |
| Outer diameter: | 1.5 - 2.1 mm | same | same | |
| Inner diameter: | 0.9 - 1.5 mm | same | same | |
| Compatibility: | ||||
| Max balloon diameter | 4.0 mm | 3.5 mm | 4.0 mm | |
| Max balloon catheter shaft size: | 3.8 Fr | 3.5 Fr | 3.8 Fr | |
| Guiding catheter: | Standard | same | same | |
| Infusion port fitting: | ISO 594 luer conical fitting | same | same | |
| Radiopacity: | via Radiopaque distal markers | same | same |
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NONCLINICAL TESTS:
Material biocompatibility, bond joint tensile strengths, infinited fatige, burst pressure, flexural Material biocompatibility, bond joint tensite strellguls, intusion patings, tip expansion resistance, and invivo animal evaluations.
TEST CONCLUSIONS:
The test results verified that the InfusaSleeve II performance is equivalent to, or exceeds the predicate InfusaSleeve II device performance.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).