(214 days)
Not Found
No
The summary describes a mechanical device for ablating plaque and does not mention any AI/ML components or functionalities.
Yes
The device is described as treating occlusive atherosclerotic disease and restoring luminal patency in peripheral vessels, indicating a direct therapeutic action on the patient's condition.
No
The device description states that the Rotablator system "ablates occlusive material and restore luminal patency," indicating it is a therapeutic device used for treatment, not diagnosis.
No
The device description explicitly lists hardware components such as an advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "percutaneous use in peripheral vessels in patients." This means it's used inside the patient's body to treat a condition.
- Device Description: The description details a mechanical system with a rotating burr designed to ablate material within blood vessels.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The Rotablator system is an interventional medical device used for treatment within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Rotablator Rotational Angioplasty system uses a high speed, rotating, diamond-coated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The A21 Rotablator system comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.
The advancer houses the air turbine and functions as a guide for the sliding elements that control burr advancement. The turbine is designed with low torque so that it will stall if it encounters resistance. This feature prevents inadvertent damage to the artery. The advancer has an air-actuated guide wire brake which is automatically actuated when the operator steps on the foot pedal to turn on the advancer. This feature prevents movement of the guide wire when the drive shaft is turning.
The catheter consists of the burr and drive shaft, the sheath, and the catheter body. The burr is attached to the end of the flexible drive shaft which is connected to an air turbine and powered by compressed air or nitrogen. The drive shaft, which has a central lumen for a guide wire to pass through, is flexible. This feature facilitates passage through tortuous arteries and around multiple sharp bends, and permits the burr to reach lesions in small distal arteries. The catheter is covered by a Teflon™ sheath which protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the drive shaft. A contrast agent can be delivered to the lesion site by flowing between the sheath and the guide catheter. The A21 peripheral catheter will be available in burr sizes ranging from 1.5 mm to 4.0 mm. The various sizes allow for maximum debulking when treating lesions in small or distal vessels as well as those in larger arteries.
The Rotablator catheter tracks over a guide wire which is passed through the lesion to be treated. The guide wire directs the catheter to the lesion and keeps it aligned within the artery. This allows the catheter tip to be redirected as it progresses around bend points, thus decreasing the possibility of the tip contacting the outer wall and potentially causing tissue damage. The guide wire has a radiopaque spring tip which facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes progress visible on fluoroscopy.
The console monitors and controls the rotational speed of the burr and continuously provides the operator with performance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange (i.e., Dynaglide™ mode). In the Dynaglide mode, the drive shaft rotates at a reduced speed of 50,000-90,000 RPM, thus allowing the physician to defeat the guide wire brake and allow the guide wire to remain in place while the catheter is withdrawn. This feature facilitates removal of the catheter from the coronary arteries. The Rotablator console is powered by house current, however, no electricity is transmitted to the advancer or to the patient.
The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting the burr to stop rapidly. The foot pedal also has a toggle switch for activating and deactivating the lower speed used during catheter exchange.
The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, hospital setting (implied by "percutaneous use" and "bypass graft surgery").
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
Bench testing was done to show that the performance of the peripheral A21 system conforms to product specifications and that it is as safe and effective as the current peripheral A19 system. Testing was conducted on performance characteristics that are influenced by the catheter's configuration and are clinically relevant.
Using statistically valid sample sizes, the testing showed with 95% confidence that there is a 99% probability that the following performance specifications will be met: dynamic stall torque, steady state stall torque, and distal flow rate.
The test also indicated the following:
- With 95% confidence, there is a 99% probability that the functional life of the catheter will be 20 minutes.
- The difference in lesion crossing time between the A19 and the A21 were not statistically significant.
Additional testing was done for further comparison of clinically relevant performance characteristics: speed versus console pressure, and stall torque versus console pressure. Five A19 1.5 mm burrs and five A19 3.0 mm burrs were tested - the two burr sizes allow for testing the two types of turbine nozzles in the A19. For the A21 system, one advancer and five catheters were tested. Only one burr size was used for the A21 since they are used with the same type of turbine nozzle.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: In Vitro Tests (Bench testing) and Biocompatibility testing. Clinical studies were not conducted.
Sample Size:
- Bench testing: Statistically valid sample sizes for dynamic stall torque, steady state stall torque, and distal flow rate. Five A19 1.5 mm burrs and five A19 3.0 mm burrs for speed/stall torque vs. pressure. One A21 advancer and five A21 catheters for speed/stall torque vs. pressure.
Key Results: - Bench Testing:
- 95% confidence, 99% probability that dynamic stall torque, steady state stall torque, and distal flow rate performance specifications will be met.
- 95% confidence, 99% probability that the functional life of the catheter will be 20 minutes.
- No statistically significant difference in lesion crossing time between A19 and A21.
- A21 runs slower than A19 at a given console pressure.
- At console pressures lower than 50 PSI, A21 delivers less torque than A19. This difference decreases at 50 PSI or greater.
- These performance differences are not significant from the user's point of view and do not affect effectiveness, as the maximum suggested operational speed of 180 KRPM can still be attained. Higher operational pressures for A21 will offset lower torques.
- Biocompatibility:
- Biological evaluation performed, included material characterization, cytotoxicity, pyrogenicity, and hemocompatibility assays.
- The infusion pathway portion of the device was evaluated as a whole composite following two EtO sterilization cycles.
- The A21 Rotablator system was found to be compatible with biological systems.
- Sterilization:
- 100% ethylene oxide (EtO) sterilized, sterility assurance level (SAL) of 10-4.
- Nonpyrogenic based on the Limulus Amebocyte Lysate (LAL) assay.
- Clinical Tests:
- No clinical studies conducted. The therapeutic benefit of the A19 Rotablator system was not changed in the design criteria for A21. All patient-contacting parts (burr, drive shaft, sheath material) are the same as in the A19 system. Changes made to facilitate the separable catheter design, improve manufacturability, reliability, and reduce cost, have no significant impact on therapeutic benefit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K970296, A19 Rotablator system
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
KG 70396
510(k) for Peripheral Rotablator® Rotational Angioplasty System with the RotaLink™ Exchangeable Catheter
1
rage d
Page v
TABLE OF CONTENTS 510(k) SUMMARY
AUG 2 9 1277
| A. | Introduction | 6 |
|---|---|---|
| B. | Device Description | 6 |
| C. | Intended Use | 8 |
| D. | Comparison to Predicate Device | 8 |
| 1. Functional Changes | 9 | |
| 2. Design and Material Modifications to Functional Components | 10 | |
| 3. Performance | 10 | |
| E. | In Vitro Tests | 10 |
| F. | Biocompatibility | 11 |
| G. | Sterilization | 11 |
| H. | Clinical Tests | 11 |
1
Page 6
510(k) SUMMARY
AUG 2 9 1997
Introduction
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A.
(
This 510(k) is for the new Rotablator® System with the RotaLink™ Exchangeable Catheter (referred to as the A21 Rotablator system throughout this summary). The A21 Rotablator system is designed to allow for the exchange of the catheter by dividing the advancer into two components: an advancer with a short drive shaft and connector, and a catheter with a long drive shaft and connector. The indications for use of this device remain the same.
Submitter: Boston Scientific Corporation Northwest Technology Center, Inc. 17425 N.E. Union Hill Road Redmond, WA 98052
- Diane Johnson Contact: Phone: (206) 556-1541 Fax: (206) 558-1400
January 23, 1997 Preparation Date:
لم العام الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الم Device Common Name: Rotational Angioplasty System Rotablator® Rotational Angioplasty System with the RotaLink™ Device Proprietary Name: Exchangeable Catheter Classification Name: Catheter, Peripheral, Atherectomy (per 21 CFR 870.4875) Classification Panel: Cardiovascular
Manufacturing Facilities: Boston Scientific Corporation Northwest Manufacturing Center, Inc. 17425 N.E. Union Hill Road Redmond, WA 98052
B. Device Description
The Rotablator Rotational Angioplasty system uses a high speed, rotating, diamond-coated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The A21 Rotablator system comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.
The advancer houses the air turbine and functions as a guide for the sliding elements that control burr advancement. The turbine is designed with low torque so that it will stall if it
2
510(k) for Peripheral Rotablator® Rotational Angioplasty System with the RotaLink™ Exchangeable Catheter
(
ﻧﻴﻮﻳﻮﻧﻴﺔ
encounters resistance. This feature prevents inadvertent damage to the artery. The advancer has an air-actuated guide wire brake which is automatically actuated when the operator steps on the foot pedal to turn on the advancer. This feature prevents movement of the guide wire when the drive shaft is turning.
The catheter consists of the burr and drive shaft, the sheath, and the catheter body. The burr is attached to the end of the flexible drive shaft which is connected to an air turbine and powered by compressed air or nitrogen. The drive shaft, which has a central lumen for a guide wire to pass through, is flexible. This feature facilitates passage through tortuous arteries and around multiple sharp bends, and permits the burr to reach lesions in small distal arteries. The catheter is covered by a Teflon™ sheath which protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the drive shaft. A contrast agent can be delivered to the lesion site by flowing between the sheath and the guide catheter. The A21 peripheral catheter will be available in burr sizes ranging from 1.5 mm to 4.0 mm. The various sizes allow for maximum debulking when treating lesions in small or distal vessels as well as those in larger arteries.
The Rotablator catheter tracks over a guide wire which is passed through the lesion to be treated. The guide wire directs the catheter to the lesion and keeps it aligned within the artery. This allows the catheter tip to be redirected as it progresses around bend points, thus decreasing the possibility of the tip contacting the outer wall and potentially causing tissue damage. The guide wire has a radiopaque spring tip which facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes progress visible on fluoroscopy.
The console monitors and controls the rotational speed of the burr and continuously provides the operator with performance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange (i.e., Dynaglide™ mode). In the Dynaglide mode, the drive shaft rotates at a reduced speed of 50,000-90,000 RPM, thus allowing the physician to defeat the guide wire brake and allow the guide wire to remain in place while the catheter is withdrawn. This feature facilitates removal of the catheter from the coronary arteries. The Rotablator console is powered by house current, however, no electricity is transmitted to the advancer or to the patient.
The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting the burr to stop rapidly. The foot pedal also has a toggle switch for activating and deactivating the lower speed used during catheter exchange.
The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.
3
510(k) for Peripheral Rotablator® Rotational Angioplasty System with the RotaLink™ Exchangeable Catheter
C. Intended Use
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
Comparison to Predicate Device D.
The A21 Rotablator system is substantially equivalent to the currently marketed Rotablator system (referred to as A19 throughout this summary). The difference between the two devices is two functional changes and several minor modifications in material and design of the A21, none of which affects function. In addition, the largest burr used in the A19 system, 4.5 mm, will not be manufactured for the A21 system.
The following table summarizes the functional and non-functional changes.
| A19 | A21 | |
|---|---|---|
| Functional | Advancer and catheter one unit. | Advancer and catheter two separate units. |
| No docking port. | Docking port to hold wireClip. | |
| Design and | ||
| Material | ||
| Changes | ||
| (no | ||
| functional | ||
| impact): | ||
| Drive | ||
| Mechanism | Adhesive bonds between bearings, turbine | |
| shaft, and bearing housing. | Press fit of turbine components into turbine | |
| housing. | ||
| Retro-reflector press fit onto turbine shaft. | Retro-reflector slip fit onto turbine shaft. | |
| Cyanoacrylate adhesive bond between | ||
| turbine shaft and pump shaft. | Ultraviolet cure adhesive bond between turbine | |
| shaft and pump shaft. | ||
| Epoxy bond between pump shaft and drive | ||
| coil. | Laser weld between drive coil and pump shaft | |
| and connectors. | ||
| Design and | ||
| Material | ||
| Changes | ||
| (no | ||
| functional | ||
| impact): | ||
| Fluid Path | Stainless steel pump rotor. | Polysulfone pump rotor. |
| Polyetherimide front plug. | Polysulfone front plug. | |
| FEP small hypo tube liner. | PTFE small hypo tube liner (same material as | |
| large hypo tube liner). | ||
| Cyanoacrylate adhesive bond between pump | ||
| rotor and pump shaft. | Pump rotor press fit onto pump shaft or pump | |
| rotor insert molded to pump shaft. | ||
| NA | Catheter connection made of ABS; new | |
| material to fluid path. | ||
| Diamond grit size: .002-.0031" | Diamond grit size: .0008-.0012" |
ندوينياك
"
4
Functional Changes 1.
Catheter and Drive Shaft Connections a.
In the A21, the drive shaft is made up of two components: the short drive shaft, which is part of the advancer, and the long drive shaft, which is part of the catheter. In the A19, the drive shaft is a single component, and the catheter and advancer are a single unit. By allowing for the separation of the catheter from the advancer, several catheters with various burr sizes can be attached to a single advancer during a procedure. This change is incorporated to facilitate the multiple-burr treatment regime used by many physicians. The connection of the catheter to the advancer involves two systems: drive shaft connection plus slide tube, and the catheter connection. Once the drive shaft and catheter are connected to the advancer, the A21 advancer/catheter is functionally equivalent to the A19 advancer/catheter.
Docking Port b.
The A21 has a new feature, the docking port. The docking port facilitates conducting the clinical procedure in several ways. First, the wireClip® torquer can be inserted into the docking port, where it is held during the procedure. Second, during an exchange procedure. when the brake defeat button has been depressed, the torquer can be inserted further into the docking port to serve two functions: the docking port holds the torquer in place which prevents spinning of the guide wire, and the torquer prevents the brake from engaging, even when the brake defeat button is not being depressed. This configuration enhances safety and efficiency because neither the operator nor additional personnel are required to hold the torquer.
5
Design and Material Modifications to Functional Components 2.
The advancer body has been changed from a solid machined plastic tube to a twopiece snap together shell, i.e., a top and a bottom. The catheter body also is a two piece snap together assembly.
3. Performance
All performance specifications for the A21 Rotablator system such as speed, infusate flow, torque, etc., are identical or more stringent than those for the A19 Rotablator system, therefore, the A21 is equivalent in performance to the A19 Rotablator system.
In Vitro Tests E.
Bench testing was done to show that the performance of the peripheral A21 system conforms to product specifications and that it is as safe and effective as the current peripheral A19 system. Testing was conducted on performance characteristics that are influenced by the catheter's configuration and are clinically relevant.
Using statistically valid sample sizes, the testing showed with 95% confidence that there is a 99% probability that the following performance specifications will be met: dynamic stall torque, steady state stall torque, and distal flow rate.
The test also indicated the following:
- With 95% confidence, there is a 99% probability that the functional life of the catheter � will be 20 minutes.
- � The difference in lesion crossing time between the A19 and the A21 were not statistically significant.
Additional testing was done for further comparison of clinically relevant performance characteristics: speed versus console pressure, and stall torque versus console pressure. Five A19 1.5 mm burrs and five A19 3.0 mm burrs were tested - the two burr sizes allow for testing the two types of turbine nozzles in the A19. For the A21 system, one advancer and five catheters were tested. Only one burr size was used for the A21 since they are used with the same type of turbine nozzle.
The results of the speed versus pressure test indicate that the A21 runs slower than the A19 at a given console pressure. The results of the stall torque versus pressure test indicate that at any given console pressure lower than 50 PSI, the A21 delivers less torque than does the A19. However, at console pressures of 50 PSI or greater, this difference decreases. These performance differences between the A19 and the A21 are not significant from the user's point of view and does not affect the A21's effectiveness because the maximum suggested operational speed of 180 KRPM can still be attained. Also, the higher operational pressures
6
required to attain a given speed for the A21 will serve to offset the lower torques of the A21 since torque increases with pressure.
Biocompatibility F.
A biological evaluation was performed on the A21 Rotablator system to give a high degree of assurance that the final product will be safe for human use. These tests included material characterization, cytotoxicity, pyrogenicity and hemocompatibility assays conducted under Good Laboratory Practices (GLP). The infusion pathway portion of the device was evaluated as a whole composite following two EtO sterilization cycles. The A21 Rotablator system was found to be compatible with biological systems.
Sterilization G.
Following final packaging and labeling, finished devices are 100% ethylene oxide (EtO) sterilized to achieve a sterility assurance level (SAL) of 104, or one nonsterile unit out of one million. The Rotablator device is nonpyrogenic based on the Limulus Amebocyte Lysate (LAL) assay.
H. Clinical Tests
Clinical studies were not conducted on the A21 design. As part of the design criteria for the A21 Rotablator system, it was specified that the therapeutic benefit of the current A19 Rotablator system not be changed. All parts that come in contact with the patient are, therefore, the same as the corresponding parts in the current system, specifically the burr, the drive shaft, and the sheath material. Any changes made to the system to facilitate the separable catheter design, improve manufacturability and reliability, and reduce the unit cost of the device, have no significant impact on the therapeutic benefit of the device, therefore, no clinical study was required.
The aspects of the device that relate to patient safety are 1) biocompatibility of the materials in the fluid contact path, 2) device sterility, 3) interaction between the burr and the vessel wall, 4) infusion of saline at the treatment site, and 5) functionality of the brake system. All of these aspects of the A21 have been tested and show the device to be safe and the clinically relevant parameters unchanged from those of the A19.
7
Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background is white.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Diane Johnson Manager, Regulatory Affairs Boston Scientific Corporation Northwest Technologies Center, Inc. 17425 N.W. Union Hill Road Redmond, Washington 98052-3376
AUG 2 9 1997
K970296 Re : Peripheral Rotablator® Rotational Angioplasty System with the RotaLink™ Enchangeable Catheter Requlatory Class: II (Two) Product Code: MCW Dated: May 29, 1997 Received: June 2, 1997
Dear Ms. Johnson:
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 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, Druq, 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
8
Page 2 - Ms. Diane Johnson
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other qeneral 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/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
9
INDICATIONS FOR USE SECTION III
Rotablator® Rotational Angioplasty System with RotaLink™ Exchangeable Device: Catheter
The Rotablator system is intended for periodate vessels in patints with I he Rotablator system is mended for persualleous are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
Qane Johnson
January 23, 1997
Date
For Boston Scientific Corporation Northwest Technology Center
Q. Danielson to T. Ryan 8/21/97
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number .