(86 days)
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).
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.
The provided text describes a 510(k) summary for a medical device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML device.
This document pertains to a resubmission for a Percutaneous Sheath Introducer where the change is in the sterilization method for a suture component of a kit. The approval is based on substantial equivalence to a predicate device, not on specific performance data against defined acceptance criteria.
Therefore, I cannot fulfill most of your request directly from the provided text. However, I can extract the relevant information that is present:
Key Takeaways from the document regarding the study and acceptance criteria:
- The device is a Percutaneous Sheath Introducer, not an AI/ML device. Therefore, the questions about AI/ML specific aspects (training set, inference, human-in-the-loop, etc.) are not applicable here.
- The submission is for a change in the sterilization process for a suture component of a kit, not for a new device design or a new AI/ML algorithm.
- The "study" described is primarily focused on demonstrating compliance with USP 25 for non-absorbable surgical sutures after the change in sterilization method (Ethylene Oxide). This is a regulatory compliance and material property assessment, not a clinical performance study with acceptance criteria often seen for new clinical devices or AI algorithms.
- The acceptance criteria are implied to be compliance with USP 25 and successful functional/biocompatibility testing for the ethylene oxide-sterilized sutures.
Based on the provided text, here's an attempt to answer your questions, highlighting what is not applicable or not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with USP 25, Nonabsorbable Surgical Sutures (for EO-sterilized sutures) | "The ethylene-oxide sterilized sutures have been demonstrated to be in compliance with USP 25, Nonabsorbable Surgical Sutures." |
| Functional testing (for EO-sterilized sutures) | "The ethylene-oxide sterilized sutures have successfully undergone functional...testing." |
| Biocompatibility testing (for EO-sterilized sutures) | "The ethylene-oxide sterilized sutures have successfully undergone...biocompatibility testing." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document.
- Data Provenance: Not specified, but given the nature of the tests (USP 25, functional, biocompatibility), it would likely be laboratory/bench testing.
- Retrospective/Prospective: Not applicable in the context of this type of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document describes testing for material properties and regulatory compliance of a physical medical device component (suture), not a clinical assessment requiring expert-established ground truth. The "ground truth" here is the standard set by USP 25.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to clinical studies and expert consensus, which is not the subject of this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests mentioned (functional, biocompatibility, USP 25 compliance) is primarily established industry and regulatory standards (specifically USP 25 for non-absorbable surgical sutures) and established laboratory testing protocols.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and thus there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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JUN 2 0 2003
510(k) Summary
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, California 92614 USA |
|---|---|
| Contact: | Jason Smith, Senior Regulatory Affairs SpecialistPhone: 949-250-2662Fax: 949-250-3579 |
| Date prepared: | March 25, 2003 |
| Trade Name: | Edwards Lifesciences Percutaneous Sheath Introducerswith Oligon™ material |
| Common Name: | Catheter Introducer (21 CFR 870.1340) |
| Predicate Devices: | Edwards Lifesciences Percutaneous Sheath Introducerswith Oligon™ materialSurgical Specialities' Sharpoint DC-0218 Suture |
| Device Description: | The Edwards Lifesciences Percutaneous Sheath Introducerswith Oligon™ material are used to access the venoussystem and to facilitate catheter insertion.Edwards Lifesciences wishes to package the EdwardsLifesciences Percutaneous Sheath Introducers withOligon™ material in a convenience kit. One of thecomponents of the kit is a silk suture. The suturemanufacturer provides the suture either gamma sterilized ornon-sterile. Edwards wishes to receive the suture non-sterile, with ethylene oxide sterilization as the finalsterilization process for the kit, including the suture. Thereason for this submission is the change in sterilizationprocess for the suture component of the kit. |
| Indications for Use: | The Edwards Lifesciences Percutaneous Sheath Introducerswith Oligon™ material are indicated for use in patientsrequiring access of the venous system and to facilitatecatheter insertion (e.g. pulmonary artery or infusioncatheter). |
| Comparative Analysis: | The introducer is identical to the predicate EdwardsLifesciences Percutaneous Sheath Introducer withOligon™ material. The ethylene oxide-sterilized sutures |
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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.
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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.
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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
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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)
§ 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).