(193 days)
LawMax™ Dilator is intended for use in the dilation of the peripheral vasculature.
LawMax™ dilator is intended to dilate the puncture tunnel of the skin, subcutaneous tissue and vascular wall. The device is compised of a dilator tube and a handle connected to its proximal end. There is a lumen in the tube center from distal end to proximal end which can accept a 0.038 inch guide wire. The tube surface is coatings which can reduce the friction during the insertion manipulation. Operator can monitor the tube using fluoroscope guidance. A handle groximal end of the tube is available to facilitate operation. There is a hemostasis valve which can be adjusted to prevent blood leaking. The specification of LawMax™ dilator is definite by the outer diameter of the cylindrical part of the tube.
The provided text is a 510(k) summary for a medical device called the LawMax™ Dilator. This document describes the device, its intended use, comparison to predicate devices, and the testing conducted to demonstrate its substantial equivalence to previously cleared devices.
Based on the nature of the device (a mechanical dilator for peripheral vasculature) and the information provided, it's highly unlikely that the 510(k) submission involved the specific types of AI-related studies and acceptance criteria questions you've asked (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details). These questions are typically relevant for AI/ML-enabled diagnostic devices or software as a medical device (SaMD), which the LawMax™ Dilator is not.
The "acceptance criteria" for the LawMax™ Dilator would be that it meets the design specifications and performs as safely and effectively as its predicate devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing detailed in the document.
Therefore, I will answer the applicable questions based on the provided text, and explicitly state when a question is not relevant or cannot be answered from the provided information.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance Statement |
|---|---|---|
| Performance Tests | Primary Dimension Test | Met all design specifications and was substantially equivalent to the predicate device. |
| Exterior Surface Condition Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Liquid Leakage Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Bending Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Solvent Resistance of Coating | Met all design specifications and was substantially equivalent to the predicate device. | |
| Thickness of Coating | Met all design specifications and was substantially equivalent to the predicate device. | |
| Simulating Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Connection Strength (tube/handle) | Met all design specifications and was substantially equivalent to the predicate device. | |
| X-Ray Visible | Met all design specifications and was substantially equivalent to the predicate device. | |
| Conical Fitting Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Sterilization | Sterilization Validation | Met all design specifications and was substantially equivalent to the predicate device. |
| Package Integrity | Met all design specifications and was substantially equivalent to the predicate device. | |
| Endotoxicity Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Biocompatibility | Cytotoxicity Test | Met all design specifications and was substantially equivalent to the predicate device. |
| Sensitization Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Intracutaneous Reactivity Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Acute Systemic Toxicity | Met all design specifications and was substantially equivalent to the predicate device. | |
| Hemolysis Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Thrombosis Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Coagulation Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Pyrogen Test | Met all design specifications and was substantially equivalent to the predicate device. |
Note: The document states that "Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalent to the predicate device." For each listed test, this implies that the performance met the specified criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. For mechanical devices undergoing performance and biocompatibility testing, sample sizes for specific tests (e.g., number of dilators tested for bending strength, number of animals for biocompatibility) would typically be detailed in the full test reports, but not usually in the 510(k) summary. The concept of "data provenance" (country of origin, retrospective/prospective) is typically associated with clinical data for diagnostic or AI devices, which is not applicable here.
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)
This question is not applicable to this type of device and its testing. The "ground truth" concept is relevant for AI/ML diagnostic performance evaluation. For a mechanical dilator, performance is assessed through engineering tests and biological safety tests, not subjective expert evaluation of "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to this type of device and its testing. Adjudication methods are typically used in clinical trials or expert review processes for diagnostic accuracy, which is not relevant for a mechanical dilator.
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
This question is not applicable. An MRMC study is done for diagnostic imaging devices where human readers interpret images, often with or without AI assistance. The LawMax™ Dilator is a mechanical dilator, not an imaging or AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The LawMax™ Dilator is a physical medical instrument, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This question is not applicable in the context of device performance as described. The "ground truth" for a mechanical dilator's performance lies in its adherence to pre-defined engineering specifications, material properties, and biological safety standards, as evaluated by direct measurement and standardized test methods rather than expert consensus on a diagnostic outcome or pathology.
8. The sample size for the training set
This question is not applicable. Training sets are used for machine learning algorithms. The LawMax™ Dilator is a mechanical device, not an AI/ML product.
9. How the ground truth for the training set was established
This question is not applicable. As stated above, this device does not involve a training set or AI/ML algorithms.
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K123842 p. 1 of 2
Premarket Notification Section 510(k) Submission LawMax™ Dilator Section III 510(K) Summary Ref No .: LT/TS/18FDA-01
Lifetech
SCIENTIFIC
Section III. 510(k) Summary
JUN 2 4 2013
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitted by:
Lily Shi Lifetech Scientific (Shenzhen) Co., Ltd Floor 1-3, Cybio Electronic Building, Langshan 2nd Street, North area of High-tech Park, Nanshan District, Shenzhen, Guangdong, 518057, P. R. China Tel: 86-755-86026416 Fax: 86-755-86026251 Email address: shixiaoli@lifetechmed.com
Date of Submission: 5 Dec 2012
Proposed Device: LawMax™ Dilator
Classification: Class II, DRE, 21 CFR 870.1310
Dilator, Vessel, For Percutaneous Catheterization
Predicate Device:
Edwards Lifesciences, LLC - RetroFlex™ Dilator Kit cleared under K093554 a)
- Estech Estech Percutaneous Dilator Insertion Kit cleared under K070749 b)
Intended Use: LawMax™ Dilator is is intended for use in the dilation of the peripheral vasculature.
Device Description: LawMax™ dilator is intended to dilate the puncture tunnel of the skin, subcutaneous tissue and vascular wall. The device is compised of a dilator tube and a handle connected to its proximal end. There is a lumen in the tube center from distal end to proximal end which can accept a 0.038 inch guide wire. The tube surface is coatings which can reduce the friction during the insertion manipulation. Operator can monitor the tube using fluoroscope guidance. A handle groximal end of the tube is available to facilitate operation. There is a hemostasis valve which can be adjusted to prevent blood leaking. The specification of LawMax™ dilator is definite by the outer diameter of the cylindrical part of the tube.
Comparison with Predicate device:
The LawMax™ Dilator is substantially equivalent to the predicate devices in intended use, design, specifications, packaging, and sterlization. For each predicate device there are slight variations, yet do not fundamentally change the scientific technology of the devices, which is to dilate vessels for intravascular devices. A summary of equivalency is in Section 6.
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Premarket Notification Section 510(k) Submission LawMax™ Dilator Section III 510(K) Summary Ref No.: LT/TS/18FDA-01
Testing Conclusion: Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalent to the predicate device, including:
- . Performance Test: _
- � Primary Dimension Test
- ゃ Exterior Surface Condition Test
- � Liquid Leakage Test
- � Bending Test
- � Solvent Resistance of Coating
- や Thickness of Coating
- ゃ Simulating Test
- � Connection Strength (tube/handle)
- � X-Ray Visible
- ゃ Conical Fitting Test
- Sterilization:
- � Sterilization Validation
- � Package Integrity
- � Endotoxicity Test
- Biocompatibility
- ゃ Cytotoxicity Test
- � Sensitization Test
- � Intracutaneous Reacitivity Test
- � Acute Systemic Toxicity
- � Hemolysis Test
- � Thrombosis Test
- �: Coagulation Test
- � Pryogen Test
SE Conclusion: Based upon the non-clinical testing noted above and in this 510(k) application, the LawMax™ Dilator meets the required standards and has demonstrated that it is as safe and effective as the predicate devices listed in this application.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEPARTMENT OF HUMAN SERVICES.USA
June 24, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Lifetech Scientific (Shenzhen) Co., Ltd. c/o Ms. Lily Shi Regulatory Affairs Manager Floor 1-3, Cybio Electronic Building Langshan Second Street Nanshan District Shenzheng, Guangdong China 518057
Re: K123842
Trade/Device Name: LawMax™ Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE Dated: May 8, 2013 Received: May 23, 2013
Dear Ms. Shi:
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
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Page 2 - Ms. Lily Shi
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Premarket Notification Section 510(k) Submission
LawMax™ Dilator
Section II Indication for Use Statement Rel No.: LT/TS/18FDA-01
Image /page/4/Picture/2 description: The image shows the logo for Lifetech Scientific. The logo consists of a stylized symbol on the left and the company name on the right. The symbol is a black circle with a white design inside, resembling an abstract letter 'S'. To the right of the symbol is the word "Lifetech" in a bold, sans-serif font, with the word "SCIENTIFIC" in a smaller font below it.
Section II. Indication for Use Statement
510(k) Number: Device Name: LawMax™ Dilator
Indication for Use:
LawMax™ Dilator is intended for use in the dilation of the peripheral vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
11-1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bra 2013
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).