(130 days)
The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vascular Sheath and is designed to assist in the placement and removal of catheters.
The Intravascular Access Introducer Sheath is a sterile single use Sheath intended Decerption placement and removal of vascular catheters, it is manufactured from polyurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and (penouiners) and re man pouch.
The provided text describes a 510(k) summary for the "Applied Medical Intravascular Access Introducer Sheath". Based on the information, here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit via equivalence) | Reported Device Performance |
|---|---|---|
| Bench Top Testing | Comparison to predicate device to ensure safety and effectiveness. | "Bench top testing was conducted and comparisons were made to the predicated device." This implies the device performed comparably to the predicate for all tested parameters. Specific performance metrics are not detailed but the conclusion is that the new device did not introduce new safety and effectiveness issues. |
| Biocompatibility | Compliance with ISO 10993-1 requirements for materials used. | "The material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements." |
| Design Control/Risk Analysis/Design Verification | Adherence to 21 CFR § 820.30, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971. Risk factors identified and addressed. Validation and verification activities completed using established methods, tests, and acceptance criteria. | "Design control, risk analysis and design verification... have been conducted in accordance with all applicable internal Applied Medical Procedures." "The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30." "The risk analysis preformed identified the risks relative to the performance requirements..." "validation and verification activities addressed the profile." "Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied." |
| Technological Characteristics | The "Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues." | The device was found to be "substantially equivalent" to the predicate devices (Applied Medical Catheter Introducer Sheath K890766 and Johnson & Johnson Cordis Avanti+ Introducer Set) for the stated indications for use, meaning its performance, safety, and effectiveness are considered to be on par with these existing devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the traditional sense for evaluating AI performance. Instead, it relies on bench testing and comparison to a predicate device. Therefore, no information on sample size for a test set or data provenance (country, retrospective/prospective) is applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical device (introducer sheath), not an AI/software device requiring expert-established ground truth from images or other data. The "ground truth" for this submission is implicitly established by the performance and safety profiles of the predicate devices and the results of the described bench testing and design controls.
4. Adjudication Method for the Test Set
Not applicable, as a test set for a comparative study involving expert adjudication is not mentioned.
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 submission is for a physical medical device and does not involve AI or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is established through:
- Performance of predicate devices: The historical safety and effectiveness of the legally marketed predicate devices (Applied Medical Catheter Introducer Sheath K890766 and Johnson & Johnson Cordis Avanti+ Introducer Set).
- Bench testing: The objective measurements and comparisons performed in a laboratory setting to ensure the device meets specified engineering and functional requirements.
- Biocompatibility testing: Standardized laboratory tests to ensure material safety.
- Compliance with regulatory standards: Adherence to established quality system regulations (e.g., 21 CFR § 820.30, ISO standards).
8. The sample size for the training set
Not applicable. This submission is for a physical medical device and does not involve a training set for an AI model.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI model or training set involved.
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KD41506
OCT 1 5 2004 510(k) SUMMARY
| 510(k) NUMBER: | |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688Phone: 949-713-8327Fax: 949-713-8205e-mail: cblake@appliedmed.com |
| CONTACT PERSON: | Cheryl BlakeVice President, Regulatory Affairs and Quality Systems |
| DATE OF PREPARATION: | June 4, 2004 |
| NAME OF DEVICE: | Applied Medical Intravascular Access Introducer Sheath |
| TRADE NAME: | Not Determined |
| COMMON OR USUAL NAME: | Catheter Introducer |
| CLASSIFICATION NAME: | Catheter Introducer (870.1340) |
SUMMARY STATEMENT:
Identification of the legally marketed: The Applied Medical Suture Clinch is substantially equivalent to the Applied Medical Catheter Introducer Sheath under Applied Medical's previous 510(k) filing number K890766 and Johnson & Johnson Cordis Avanti+ Introducer Set.
Description: The Intravascular Access Introducer Sheath is a sterile single use Sheath intended Decerption placement and removal of vascular catheters, it is manufactured from polyurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and (penouiners) and re man pouch.
Intended Use: The Applied Medical Intravascular Access Introducer Sheath is indicated for Intended Use. The Applied interest vascular Sheath and is designed to assist in the placement and removal of catheters.
Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated device.
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Summary of Technological Characteristics: The Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues when or equivalent in processal material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements.
Design Control / Risk Analysis/Design Verification: Design control, risk analysis and design Design Court of I Last rizes whiect of this Special 510(k) have been conducted in accordance with all applicable internal Applied Medical Procedures. The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30. The risk analysis preformed identified the risks relative to the performance requirements, as specified by Applied Medical internal procedures for risk analysis. The Design Risk Assessment Profile was conducted in accordance to Applied Medical internal Stand Operating Procedures, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30, validation and verification activities addressed the profile. Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied.
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Image /page/2/Picture/13 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 2004
Applied Medical Resources Corporation c/o Ms. Cheryl Blake Vice President, Regulatory Affairs and Quality Systems 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
K041506 Re:
K041500
Trade/Device Name: Applied Medical Intravascular Access Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: September 25, 2004 Received: September 30, 2004
Dear Ms. Blake:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreating of the enactment date of the Medical Device Amendments, or to conninered pror co ria) 2011-12-11 in accordance with the provisions of the Federal Food, Drug, de vices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mererory mains of the Act include requirements for annual registration, listing 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.
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
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Page 2 - Ms. Cheryl Blake
rage = = = = = = = = = = = = = = = = = = = = = = = forth in the quality systems (QS) regulation (21 CFR 1 at 620); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Sectio product radiation control provisions (Sections 33 -342 of the first (Section S10(K)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your device to a l premarket notification. The FDA finding of substantial equivalite of 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
ntitled, If you desire specific advice for your device on on 1805mile the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the regulation of contact the Office of Compliance at (240) 2/0-0120. THBO, PR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may "Misbranding by reference to premarket nouthication " (21 cm the Division of Small
other general information on your responsibilities under the Act from the Division of Small other general information on your responsionities uner and the more of the more (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free man.ht Manufacturers, International and Consumer Assistance at its towards.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. bochner
E
B
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
510(k) Number (if known): ___K041506
Device Name:__Intravascular Access Introducer Sheath
Indications For Use: The Applied Medical Intravascular Access Introducer Sheath is
t Sheath is and the secure assess to the poripheral vascular Sheath and is designed to Indications For Use: The Applied Medical Intravasoular Sheath and is designed to
indicated for percutaneous access to the peripheral vascular Sheath and is designed to
r an indicated for peroutanosus as a moval of catheters.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Lachner
(Division Sign-Off) (Division of Cardiovascular Devices
510(K) Number_KO(K) Number_KO
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).