(193 days)
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI/ML terms or data-driven performance metrics.
Yes.
The device is intended for "dilation of the peripheral vasculature," which is a medical intervention aimed at treating a physical condition.
No
Explanation: The device is described as a dilator for the peripheral vasculature, primarily for mechanical dilation to facilitate other procedures. It does not perform any diagnostic function such as identifying, measuring, or analyzing medical conditions or disease states.
No
The device description clearly outlines physical components like a dilator tube, handle, lumen, and hemostasis valve, indicating it is a hardware device.
Based on the provided information, the LawMax™ Dilator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the dilation of the peripheral vasculature." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device used for mechanical dilation of tissue and blood vessels. It does not describe a reagent, instrument, or system used to examine specimens from the human body.
- Anatomical Site: The device is used on the "Peripheral vasculature," which is within the patient's body.
- Input Imaging Modality: While fluoroscope guidance is used, this is for visualizing the device's placement within the body, not for analyzing a biological sample.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The LawMax™ Dilator is a surgical/interventional device used directly on the patient.
N/A
Intended Use / Indications for Use
LawMax™ Dilator is intended for use in the dilation of the peripheral vasculature.
Product codes
DRE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
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
- Exterior Surface Condition Test
- Liquid Leakage Test
- Bending Test
- Solvent Resistance of Coating
- Thickness of Coating
- Simulating Test
- Connection Strength (tube/handle)
- X-Ray Visible
- Conical Fitting Test
- Sterilization:
- Sterilization Validation
- Package Integrity
- Endotoxicity Test
- Biocompatibility
- Cytotoxicity Test
- Sensitization Test
- Intracutaneous Reacitivity Test
- Acute Systemic Toxicity
- Hemolysis Test
- Thrombosis Test
- Coagulation Test
- Pryogen Test
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
§ 870.1310 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).
0
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.
1
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.
2
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
3
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
4
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)