(86 days)
Not Found
Not Found
No
The 510(k) summary describes a change in the sterilization process for a suture component of a sheath introducer kit. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a percutaneous sheath introducer and suture, used to access the venous system and facilitate catheter insertion, which are procedural tools rather than devices that directly treat a disease or condition.
No
Explanation: The device is indicated for accessing the venous system and facilitating catheter insertion, which are procedural functions, not diagnostic ones. It does not mention any function related to identifying medical conditions or diseases.
No
The device description clearly describes a physical medical device (Percutaneous Sheath Introducers with Oligon™ material) and a component (silk suture). The submission is related to a change in the sterilization process for a physical component of a kit containing these physical devices. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access the venous system and facilitate catheter insertion. This is a direct interaction with the patient's body for a medical procedure, not for examining specimens from the body to provide diagnostic information.
- Device Description: The device is a sheath introducer and a suture, both used for physical access and manipulation within the body.
- No mention of in vitro testing: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body for diagnostic purposes.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are used to access the venous system and to facilitate catheter insertion.
Edwards Lifesciences wishes to package the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material in a convenience kit. One of the components of the kit is a silk suture. The suture manufacturer provides the suture either gamma sterilized or non-sterile. Edwards wishes to receive the suture non-sterile, with ethylene oxide sterilization as the final sterilization process for the kit, including the suture. The reason for this submission is the change in sterilization process for the suture component of the kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
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)
The ethylene-oxide sterilized sutures have successfully undergone functional and biocompatibility testing. They have been shown to be in compliance with USP 25, Nonabsorbable Surgical Sutures.
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.
Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material, Surgical Specialities' Sharpoint DC-0218 Suture
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
JUN 2 0 2003
510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, California 92614 USA |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Smith, Senior Regulatory Affairs Specialist
Phone: 949-250-2662
Fax: 949-250-3579 |
| Date prepared: | March 25, 2003 |
| Trade Name: | Edwards Lifesciences Percutaneous Sheath Introducers
with Oligon™ material |
| Common Name: | Catheter Introducer (21 CFR 870.1340) |
| Predicate Devices: | Edwards Lifesciences Percutaneous Sheath Introducers
with Oligon™ material
Surgical Specialities' Sharpoint DC-0218 Suture |
| Device Description: | The Edwards Lifesciences Percutaneous Sheath Introducers
with Oligon™ material are used to access the venous
system and to facilitate catheter insertion.
Edwards Lifesciences wishes to package the Edwards
Lifesciences Percutaneous Sheath Introducers with
Oligon™ material in a convenience kit. One of the
components of the kit is a silk suture. The suture
manufacturer provides the suture either gamma sterilized or
non-sterile. Edwards wishes to receive the suture non-
sterile, with ethylene oxide sterilization as the final
sterilization process for the kit, including the suture. The
reason for this submission is the change in sterilization
process for the suture component of the kit. |
| Indications for Use: | The Edwards Lifesciences Percutaneous Sheath Introducers
with Oligon™ material are indicated for use in patients
requiring access of the venous system and to facilitate
catheter insertion (e.g. pulmonary artery or infusion
catheter). |
| Comparative Analysis: | The introducer is identical to the predicate Edwards
Lifesciences Percutaneous Sheath Introducer with
Oligon™ material. The ethylene oxide-sterilized sutures |
1
have been demonstrated to be in compliance with USP 25, Nonabsorbable Surgical Sutures.
- The ethylene-oxide sterilized sutures have successfully Functional/Safety undergone functional and biocompatibility testing. They Testing: have been shown to be in compliance with USP 25, Nonabsorbable Surgical Sutures.
Conclusion: The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are substantially equivalent to the predicate devices. The ethylene-oxide sterilized sutures used in the The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2003
Edwards Lifesciences LLC c/o Mr. Jason Smith One Edwards Way Irvine, CA 92614
Re: K030944
Percutaneous Sheath Introducers with Oligon™ Material Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 25, 2003 Received: March 26, 2003
Dear Mr. Smith:
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. Iisting 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 such 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.
3
Page 2 - Mr. Jason Smith
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 (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. This letter will allow you to begin 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 (301) 594-4648. 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 vours.
C. Jefferson Maynes
Bram Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material
Indications For Use:
The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). =
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | C. Aelen Mayal F. Bo Zuckerman |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | |
| Prescription Use | ✓ |
| OR | |
| Over-The-Counter Use | |
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)