(9 days)
The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.
The RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET™ 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET™ Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.
The provided text is a 510(k) premarket notification for the RX ACCUNET™ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study results with precise acceptance criteria and detailed performance data like a PMA (Premarket Approval) would.
Therefore, many of the requested elements for a detailed study description are not present in this document. The document explicitly states that "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System" and that the submission is for a "3 in 1 packaging configuration." The "Performance Data" section only mentions "packaging integrity studies."
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., specific sensitivity, specificity, accuracy thresholds). The overarching acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
- Reported Device Performance: The only performance data mentioned is related to "packaging integrity studies." No clinical performance metrics (like efficacy in embolic capture, complication rates, or patient outcomes) are provided for the device itself.
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Performance (Clinical) | Substantial equivalence to predicate device in terms of safety and efficacy | Not directly reported in this document. Implicitly met by substantial equivalence. |
| Packaging Integrity | (Implicit: demonstrate safety and effectiveness of the packaging) | "The results of the packaging integrity studies have demonstrated the safety and effectiveness of the proposed RX ACCUNET™ Embolic Protection System '3 in 1 packaging configuration.'" |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/not provided for clinical performance testing, as no new clinical study data on device performance is presented. The submission focuses on packaging changes and substantial equivalence.
- Data Provenance: Not applicable for clinical performance. The packaging studies would likely be internal Guidant testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable, as no new clinical test set requiring expert ground truth establishment for device performance is described.
4. Adjudication Method for the Test Set
- Not applicable, as no new clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a TRMC study was not done, as this is solely a 510(k) submission for a packaging change, demonstrating substantial equivalence, not a new clinical study for effectiveness.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a medical device (embolic protection system), not an AI algorithm.
7. Type of Ground Truth Used
- Not applicable for clinical performance. For the packaging studies, the "ground truth" would be the verified integrity and sterility of the packaged device after testing.
8. Sample Size for the Training Set
- Not applicable, as no new clinical performance data or AI model training data is described.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary derived from the document:
The 510(k) K052166 for the RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration" is a submission demonstrating substantial equivalence to previously cleared predicate devices (RX ACCUNET™ Embolic Protection Systems K042218 and RX ACCUNET™ 2 Recovery Catheter K042908).
The document explicitly states:
- "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System."
- The "Technological Characteristics" are considered "substantially equivalent" in materials, biocompatibility, performance properties, sterilization, and packaging to the currently marketed predicate devices.
The only performance data mentioned are packaging integrity studies, which "demonstrated the safety and effectiveness of the proposed RX ACCUNET™ Embolic Protection System '3 in 1 packaging configuration.'" No details about these packaging studies (sample size, specific tests, acceptance criteria for packaging) are provided in this summary.
This 510(k) does not present a new clinical study to prove the device meets specific performance criteria beyond the existing predicate devices. The "study" referenced in the document is effectively the demonstration of substantial equivalence through comparison of technological characteristics and confirmation of packaging integrity for the new configuration.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2005
Guidant Endovascular Solutions c/o Ms. Julia Anastas Advisor, Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054
Re: K052166
RX ACCUNET™ Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: August 8, 2005 Received: August 9, 2005
Dear Ms. Anastas:
This letter corrects our substantially equivalent letter of August 18, 2005.
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 (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 (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.
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Page 2 - Ms. Julia Anastas
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 (OS) 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 continue 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 (240) 276-0120. 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dmnel R. Vichner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052166
Device Name:
RX ACCUNET™ Embolic Protection System
Indications For Use:
The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auley B. Bvan
(Division Sign-Off)
Division of Cigit Off
Division of Cardiovascular Devices
Page 1 of _1
510(k) Number_KO5266
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K052166 p. 1 of 2
RX ACCUNET™ Embolic Protection System "3 in 1 Packaging Configuration" Special 510(k)
GUIDANT
AUG 1 8 2005
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant Corporation |
|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta Clara, CA 95052 |
| Telephone:Fax: | 408-845-2201408-845-2304 |
| Contact Person: | Julia Anastas |
| Date Prepared: | August 8, 2005 |
| Device Trade Name: | RX ACCUNET™ Embolic Protection System |
| Device Common Name: | Embolic Protection System |
| Device Classification Name: | Embolic Protection System |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The proposed RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration" is substantially equivalent to the currently marketed RX ACCUNET™ Embolic Protection System and RX ACCUNET™ 2 Recovery Catheter.
Device Description:
The RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET™ 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET™ Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.
Confidential
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Intended Use:
The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and The KX AOOONE T - Embolio Protoction and remove embolic material (thrombus / debris) while embolic protection oyoton to contain or carotid arteries. The diameter of the performing anglopidsty and cloning promote should be between 3.25 mm and 7.0 mm.
Technological Characteristics:
No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System.
The RX ACCUNET™ Embolic Protection System is substantially equivalent to the RX The RX ACCONET - Embolic Protection Systems (K042218) and the RX ACCUNET™ 2 Recovery Catheter (K042908) with regard to device design, principles of operation, materials, and Oather (189200) with rogard to asign attributes are the same or similar for both the subiect device and the predicate device:
- Rapid exchange systems .
- Filter based technology .
- Polvurethane filter membrane .
- Nitinol filter/basket component .
- Compatibility with .014" guidewires ●
- Compatibility with 6F guide catheters .
- Available in 190 and/or 300 cm lengths .
- Accommodates same vessel sizes .
- Radiopaque guidewire tips and/or delivery sheath tips .
- Radiopaque markers on filter ●
- Delivery System /Recovery Catheter compatability
Comparisons of the subject and predicate devices show that technological characteristics Such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices.
Performance Data:
The results of the packaging integrity studies have demonstrated the safety and effectiveness of the proposed RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration."
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).