(79 days)
The Adelante® Breezeway Delivery Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.
The provided text is a 510(k) summary for a medical device called the Adelante® Breezeway Delivery Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices for expanded indications. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI performance, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document explicitly states: "This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels."
This means the submission focuses solely on expanding the stated uses for a device that was previously cleared (K101497) and has not undergone any changes itself. Therefore, it relies on the previous clearance and the substantial equivalence to existing predicate devices for the expanded indications, rather than new performance studies with specific acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. The document does not describe a study involving performance metrics, sample sizes, expert adjudication, or AI.
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K122958 pg 1 of 2
510(k) SUMMARY
DEC 1 3 2012
| Device Name | Device Trade name | Common/classification name |
|---|---|---|
| Delivery Sheath, Model Adelante®Breezeway | Introducer, Catheter | |
| Address andRegistration # | Manufacturer | Sterilization Site |
| Oscor Inc.3816 De Soto BoulevardPalm Harbor, FL 34683 | 1. International SterilizationLaboratory Inc. (ISL)217 Sampey Road, Groveland, FL34736 | |
| 2. Oscor DMB Sterilizer3816 De Soto Boulevard, PalmHarbor, FL 34683 | ||
| 3. Oscor Caribe, LLCAvenida Las Americas, Nave I-2Santo Domingo, Dom. Republic | ||
| Contact | Mila DoskocilV.P. of Regulatory Affairs & QualityAssurance | mdoskocil@oscor.com727-937-2511 |
| FDA Registration # | FDA Registration # | |
| 1035166 | 1061927 (ISL)10351663004785273 | |
| Device Class | Introducers, catheters, are classified as Class II, Reg No. 870.1340, codeDYB | |
| Type of 510k | Traditional | |
| Reason for 510k | Addition of indications into the Indications for Use statement. | |
| Predicate DeviceInformation | Thomas Medical; Reinforced Catheter Introducer system, K081341 | |
| Terumo Medical Corp., Destination Guiding Sheath, K081045 | ||
| Arrow (sub. Teleflex), Arrow-Flex Sheath Introducer Set, K970229 |
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Labeling and Indications for Use
Proposed IFU only with modified Indications for Use statement is attached.
Previously cleared Indications for Use
The Adelante Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
Proposed Indications for Use:
The Adelante® Breezeway Delivery Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
The Indications for Use statement is attached.
Device This is a modification to Indications for Use statement only. There was Description. no change in the text of IFU and method of use. Modification and Comparison to Predicate devices
There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.
Modification of Indications for Use statement was in the addition of indications for placement into vasculature and renal arteries, but restricted to peripheral placements only and excluding neural placements. The reason for modification is explained in the Rationale and Evaluation document attached.
The use of Breezeway delivery sheath has been compared to the predicate devices and found comparable to:
Thomas Medical Intended Use (see the attached information in section Predicate Devices):
The "Reinforced Catheter Introducer" is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.
Terumo, Intended Use (see the attached information in section Predicate Devices):
"Destination" is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity, renal arteries, and carotid arteries.
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::
| ModificationStatement | This labeling modification has not altered the fundamental technology andthe intended use methods from the predicate devices. |
|---|---|
| SubstantialEquivalence | The additional indications for Adelante® Breezeway Delivery Sheathdescribed in this submission are, in our opinion, substantially equivalent tothe predicate devices and other similar introducer/guiding sheaths incommercial distribution. |
. .
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mila Doskocil Vice President of Regulatory Affairs & Quality Assurance Oscor Inc. 3816 De Soto Boulevard Palm Harbor, FL 34683
Re: K122958
Trade/Device Name: Adelante Breezeway Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 21, 2012 Received: September 25, 2012
Dear Mila Doskocil:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
DEC 1 3 2012
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Page 2 - Mila Doskocil
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
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 Statement
510k Number (if known) - K122958
Device Name: Adelante® Breezeway Delivery Sheath
The Adelante® Breezeway Delivery Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96) Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
OR
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L
(Division Sign-Off) Division of Cordionascular Dycloss K122958 510(k) Number
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).