(79 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the submission as a modification to the Indications for Use only, with no change to the device itself.
No
The device is a steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices, not for providing therapy itself.
No
The device is described as a "steerable guiding sheath" intended for the "introduction of diagnostic and therapeutic devices," but it is not itself a diagnostic device. It facilitates the use of other devices.
No
The device description explicitly states it is a "steerable guiding sheath," which is a physical medical device used for introducing other devices into the vasculature. The submission is a modification to the Indications for Use of an already cleared hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of diagnostic and therapeutic devices into the human vasculature. This describes a device used within the body for procedural purposes, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description focuses on a steerable guiding sheath, which is a physical tool used in medical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Adelante Destino Steerable Guiding 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use.
There is no modification to the device itself. The Adelante Destino Steerable Guiding Sheath has been cleared in K120459 and will remain intact and no modification 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
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)
Not Found
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.
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
§ 870.1340 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).
0
510(k) SUMMARY
DEC | 3 2012 |
.
| Device Name | Device Trade name | Common/classification name |
|---|---|---|
| Address and | ||
| Registration # | Steerable Guiding Sheath, Model | |
| Adelante Destino | Introducer, Catheter | |
| Manufacturer | Sterilization Site | |
| Oscor Inc. | ||
| 3816 De Soto Boulevard | ||
| Palm Harbor, FL 34683 | 1. International Sterilization | |
| Laboratory Inc. (ISL) | ||
| 217 Sampey Road, Groveland, FL | ||
| 34736 |
- Oscor DMB Sterilizer
3816 De Soto Boulevard, Palm
Harbor, FL 34683 - Oscor Caribe, LLC
Avenida Las Americas, Nave I-2
Santo Domingo, Dom. Republic |
| Contact | Mila Doskocil | mdoskocil@oscor.com |
| | V.P. of Regulatory Affairs & Quality
Assurance | 727-937-2511 |
| | FDA Registration #
1035166 | FDA Registration #
1061927 (ISL)
1035166
3004785273 |
| Device Class | Introducers, catheters, are classified as Class II, Reg No. 870.1340, code
DYB | |
| Type of 510k | Traditional | |
| Reason for 510k | Addition of indications into the Indications for Use statement. | |
| Predicate Device
Information | Boston Scientific, Z flex 270 Steerable Sheath, K112541 | |
| | Enpath Medical, Steerable Sheath, K061119 | |
| | CryoCath Technologies, FlexCath Steerable Sheath, K081049 | |
18193
1
Intended Use
Proposed IFU only with modified Indications for Use statement is attached.
Previously cleared Indications for Use
The Adelante Destino Steerable Guiding Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
Proposed Indications for Use:
The Adelante Destino Steerable Guiding 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 Description, Modification and Comparison to Predicate devices
This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use.
There is no modification to the device itself. The Adelante Destino Steerable Guiding Sheath has been cleared in K120459 and will remain intact and no modification 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 Destino guiding sheath has been compared to the predicate devices and found comparable to:
Boston Scientific: Z flex 270 Steerable Sheath is indicated for use to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature and into the chambers of the heart.
Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
CryoCath Technologies: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
2
| K122960 | pg 3 of 3 |
|---|---|
| --------- | ----------- |
.
.
:
· · ·
.
| Modification | This labeling modification has not altered the fundamental technology and |
|---|---|
| Statement | the intended use methods from the predicate devices. |
| Substantial | |
| Equivalence | The additional indications for Adelante Destino Steerable Guiding Sheath |
| described in this submission are, in our opinion, substantially equivalent to | |
| the predicate devices and other similar introducer/guiding sheaths in | |
| commercial distribution. |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
and the comments of the comments of the comments of
:
1
:
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
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: K122960
Trade/Device Name: Adelante Destino Steerable Guiding 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
4
Page 2 - Mila Doskocil
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.
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. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510k Number (if known) K122960
Device Name: Steerable Guiding Sheath, model Adelante Destino
The steerable guiding sheath, model Adelante Destino 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.
· ·
OR Over-The-Counter Use Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K122960