(28 days)
No
The device description and performance summary focus on mechanical components and standard medical device testing, with no mention of AI or ML.
No
The device is described as an introducer to facilitate the insertion of leads and catheters, not to provide therapy itself.
No
The device is described as an introducer for cardiac leads and catheters, facilitating access to the venous vascular system. Its purpose is to provide a conduit for other devices, not to diagnose a medical condition.
No
The device description clearly outlines physical components like sheaths, dilators, needles, syringes, and guidewires, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing a transvenous conduit for introducing cardiac leads and catheters into the venous vascular system. This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device used to access blood vessels for the purpose of inserting other medical devices (leads and catheters). This aligns with a surgical/interventional tool.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is a tool used during a medical procedure to facilitate the insertion of other devices.
N/A
Intended Use / Indications for Use
The Peel-Away Introducers are intended to provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system.
Product codes
DYB
Device Description
The Peel-Away introducers provide cardiovascular leads and catheters access to the venous vascular system for cardiac surgery procedures. Peel-Away Introducer sheaths haft. The sheath is the outer component and the dilator fits inside the sheath with the distal end protruding out. A needle, which is connected to the syringe, is used to gain access to the vessel. After blood flow is established, the syringe is removed and a quidewire is inserted through the needle and advanced into the vessel. The assembled sheath/dilator combination is advanced over the guidewire into the vessel. At the proximal end of the sheath is a t-handle hub, which is designed to splitand facilitate the peeling action of the sheath tubing is designed to peel continuously and symmetrically for safe removal of the introducer while maintaining venous access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous vascular 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 addition of the Exel syringe and modification of the packaging, biocompatibility, and sterilization testing. Completion of all verification and validation activities demonstrated that the syringe meets its predetermined design and performance specifications, and that the peel-away introducer with the new syringe accessory is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 1, 2023
Abbott Medical Chidalu Mozie Regulatory Affairs Specialist 15900 Valley View Court Sylmar, California 91342
Re: K230283
Trade/Device Name: Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 31, 2023 Received: February 1, 2023
Dear Chidalu Mozie:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hetal B. Patel -S
Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Peel-Away Introducer (405104, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405154, 405254, 405269,
405270, 405404, 405408, 405412, 405416, 405420, 405422, 405424, 405428)
Indications for Use (Describe)
The Peel-Away Introducers are intended to provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared on: 2023-01-31
| Contact Details |
|---|
| ----------------- |
21 CFR 807.92(a)(1)
| Applicant Name | Abbott Medical |
|---|---|
| Applicant Address | 15900 Valley View Court Sylmar CA 91342 United States |
| Applicant Contact Telephone | 8172333219 |
| Applicant Contact | Ms. Chidalu Mozie |
| Applicant Contact Email | chidalu.mozie@abbott.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) |
|---|---|
| Common Name | Catheter introducer |
| Classification Name | Introducer, Catheter |
| Regulation Number | 870.1340 |
| Product Code | DYB |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K013029 | Seal Away CS Introducer Kit | DYB |
Device Description Summary 21 CFR 807.92(a)(4)The Peel-Away introducers provide cardiovascular leads and catheters access to the venous vascular system for cardiac surgery procedures. Peel-Away Introducer sheaths haft. The sheath is the outer component and the dilator fits inside the sheath with the distal end protruding out. A needle, which is connected to the syringe, is used to gain access to the vessel. After blood flow is established, the syringe is removed and a quidewire is inserted through the needle and advanced into the vessel. The assembled sheath/dilator combination is advanced over the guidewire into the vessel. At the proximal end of the sheath is a t-handle hub, which is designed to splitand facilitate the peeling action of the sheath tubing is designed to peel continuously and symmetrically for safe removal of the introducer while maintaining venous access.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Peel-Away Introducers are intended to provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system. K230283 Page 1 of 2
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Indications for Use Comparison
21 CFR 807.92(a)(5)
Peel Away Introducer kits, with the new replacement syringe accessory, have the following similarities to the predicate devices (Seal Away introducer kits) which previously received 510(k) clearance (K013029):
- · have the same underlying intended use,
- · have the same fundamental scientific technology,
- · are sterilized using the same processes.
ln summary, the Peel Away Introducer products described in this submission are substantially equivalent to the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The new syringe accessory has the same technological characteristics as the syringe accessory in the currently marketed Peel-Away Introducer kits, with only minimal changes to the syringe material to ensure compliance with current regulatoryrequirements and standards.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The addition of the Exel syringe and modification of the packaging, biocompatibility, and sterilization testing. Completion of all verification and validation activities demonstrated that the syringe meets its predetermined design and performance specifications, and that the peel-away introducer with the new syringe accessory is substantially equivalent to the predicate device.