6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. PZMedical Technology Co., Ltd. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114 #### Re: K212105 Trade/Device Name: 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025ZF Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: July 1, 2021 Received: July 6, 2021 #### Dear Mr. Kamm: 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. 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 August 23, 2021 {1}------------------------------------------------ 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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212105 Device Name 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF; Indications for Use (Describe) Solid State X-ray Imager (Flat Panel/Digital Imager) Indicated for use in generating radiographic images of human anatomy. Intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, angiographic, and mammographic applications. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary K212105 Image /page/3/Picture/1 description: The image shows the logo for PZ Medical. The logo consists of a blue emblem above the words "PZ MEDICAL" in blue font. The emblem is made up of three blue squares, with a stylized "Z" shape running through them. The text is in a bold, sans-serif font. ## PZMEDICAL TECHNOLOGY CO., LTD. 5F, Building 13 No. 2 Suide Road Putuo District Shanghai, CN 200331 #### Administrative Information 1. Submitter: PZMEDICAL TECHNOLOGY CO., LTD. Submission contact person: Thomas Gourgon tgourgon@pzimaging.com Contact telephone: 310-381-3800 Date prepared: July 23, 2021 ldentification: 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF 2. Classification Name: Stationary X-Ray System Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: MQB - 3. Substantially equivalent device: Manufacturer: Trade Name: PZMEDICAL TECHNOLOGY CO., LTD. Models 3543A, 4343A, 2929A and A843B K170480 Stationary X-Ray System Radiology 21 CFR §892.1680 Class II MQB ## 4. Device description: 510(k) Number: Device Class: Product Code: Classification Name: Classification Panel: Classification Regulation: The PZMEDICAL devices are used in medical x-ray imaging systems. The product can only be used by trained personnel of medical facilities. The product is only used for diagnostic x-ray image acquisition applications. The flat panel detector consists of a Csl scintillator screen and thin-film transistors. The scintillator screen converts the x-rays into visible light. Thin-film transistors convert the visible light to an electrical charge. The flat panel detector can then obtain a digital image by analog to digital conversion and associated circuits. These panels can be used to acquire diagnostic x-ray images as an upgrade to traditional film systems. They can be used wired (Ethernet) or wirelessly (Wi-Fi) and are powered either by AC Line or by rechargeable batteries. The various models are constructed similarly to our previous models cleared in K170480. The suffix "ZF" means FINE pixel size, 99 µm Z means standard pixel size, 139 µm. All models have a battery life indicator. The supporting software PZDR is functionally the same as provided with the predicate. The software performs acquisition of the RAW image and converts it to DICOM format and performs operations as described in the comparison table below. It is functionally unchanged from the predicate software. {4}------------------------------------------------ This software consists of following modules which provides a work flow of patient study: --Patient Management: including patient registration, work list, study management. - --Study operation: including body part selection, study items selection, image acquisition. --Image preview: including display, layout and processing of image. Also tool options for advanced operation. --Configuration: including configuration of system, study and user management, especially the configuration for work list and storage. - 5. Indications for Use: Solid State X-ray Imagers (Flat Panel/Digital Imager) Indicated for use in generating radiographic images of human anatomy. Intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, angiographic, and mammographic applications. | Comparable | K170480 Models 3543A,<br>4343A, 2929A and A843B | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF,<br>3030Z, 3025Z, 3025ZF | Comparison<br>Results | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Indications for use | Solid State X-ray Imagers<br>(Flat Panel/Digital Imager)<br>are indicated for use in<br>generating radiographic<br>images of human anatomy.<br>They are intended to<br>replace radiographic<br>film/screen systems in all<br>general-purpose diagnostic<br>procedures, excluding<br>dental, fluoroscopic,<br>angiographic, and<br>mammographic<br>applications. | Solid State X-ray Imagers (Flat Panel/Digital<br>Imager) Indicated for use in generating<br>radiographic images of human anatomy.<br>Intended to replace radiographic film/screen<br>systems in all general-purpose diagnostic<br>procedures, excluding dental, fluoroscopic,<br>angiographic, and mammographic applications. | SAME | | Digital X-Ray<br>Detectors | Models 3543A, 4343A,<br>2929A and A843B | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF,<br>3030Z, 3025Z, 3025ZF | New Models | | Detector Sizes<br>(Inches) | 12 x 12 inch<br>14 x 17 inch<br>17 x 17 inch<br>42 x 17 inch | 12×10 inch<br>12×12 inch<br>14 x 17 inch<br>17 x 17 inch<br>26×17 inch<br>34× 14 inch | The 42 inch<br>size remains<br>available but<br>three new<br>sizes are<br>added. | # 6. Technological characteristics: Comparison Table {5}------------------------------------------------ | Comparable<br>Properties | K170480 Models 3543A,<br>4343A, 2929A and A843B | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF,<br>3030Z, 3025Z, 3025ZF | | | Comparison<br>Results | | |--------------------------|-------------------------------------------------|----------------------------------------------------------------------------|------------------|----------------------------------------------------|-------------------------------------------|--| | | | Model | Pixel Pitch (µm) | | | | | | | 3025Z | | 139 | Similar to or<br>better than<br>predicate | | | | | 3025ZF | | 77 | | | | | | 3030Z | | 139 | | | | | 140 µm | 3543Z | | 139 | | | | Pixel Pitch | | 3543ZF | | 99 | | | | | | 4343Z | | 139 | | | | | | 4343ZF | | 99 | | | | | | 4386Z | | 139 | | | | | | 6543Z | | 139 | | | | | | Model | | (lp/mm) | | | | | | 3025Z | | 3.6 | | | | | | 3025ZF | | 5.9 | | | | Limiting | | 3030Z | | 3.6 | Same as or | | | | 3.6 lp/mm | 3543Z | | 3.6 | better than | | | Resolution | | 3543ZF | | 4.9 | predicate | | | | | 4343Z | | 3.6 | | | | | | 4343ZF | | 4.9 | | | | | | 4386Z | | 3.6 | | | | | | 6543Z | | 3.6 | | | | | | The DQE values at 2 lp/mm are listed in the table<br>below (only for Csl): | | | Similar<br>performance, | | | | 32% at 2 lp/mm (Csl)<br>15% at 2 lp/mm (GOS) | 3025ZF | 3543ZF<br>4343ZF | 6543Z; 4386Z;<br>4343Z; 3543Z;<br>3030Z; 3025Z | Only CSI is | | | DQE | | | | | | | | | | 36% | 37% | 35% | the new | | | | | | | | models | | | | | The MTF value at 2 lp/mm are listed in the table<br>below (only for Csl): | | | | | | MTF | 33% at 2 lp/mm (Csl)<br>24% at 2 lp/mm (GOS) | 3025ZF | 3543ZF<br>4343ZF | 6543Z<br>4386Z<br>4343Z<br>3543Z<br>3030Z<br>3025Z | Similar or<br>better<br>performance | | | | | 43% | 42% | 39% | | | | A/D Conversion | 16 bit | 16 bit | | | SAME | | {6}------------------------------------------------ | Comparable<br>Properties | K170480 Models 3543A,<br>4343A, 2929A and A843B | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF,<br>3030Z, 3025Z, 3025ZF | Comparison<br>Results | | | | | | | | | | | | | | | | | | | | | | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------|--|---------------| | Active Area | 4343A: 430.08 x 430.08 mm<br>or 16.9 x 16.9 inch | Model Active Area 3025Z 290×250 mm or 11.4×9.8 inch 3025ZF 300×240 mm or 11.8×9.4 inch 3030Z 290×290 mm or 11.4×11.4 inch 3543Z 350×430 mm or 13.8 x 16.8 inch 3543ZF 350×430 mm or 13.8 x 16.8 inch 4343Z 430×430 mm or 16.9 x 16.9 inch 4343ZF 430×430 mm or 16.9 x 16.9 inch 4386Z 430×860 mm or 13.8×33.5 inch 6543Z 650×430 mm or 25.6×16.9 inch | | | | | | | | | | | | | | | | | | | | | Similar range<br>of active<br>areas | | | | | 3543A: 350.00 x 427.28 mm<br>or 13.8 x 16.8 inch | | | | | | | | | | | | | | | | | | | | | | | | | | | 2929A: 286.72 x 286.72 mm<br>or 11.3 x 11.3 inch | | | | | | | | | | | | | | | | | | | | | | | | | | | A843B: 1075.2 x 430.08 mm<br>or 42.3 x 16.9 inch | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Dimensions | 4343A: 460 x 460 x 15 mm<br>3543A: 383 x 460 x 15 mm | Model Dimensions ( W ×L ×H) 3025Z 315×278×15 mm 3025ZF 328×268×15 mm 3030Z 315×315×15 mm 3543Z 460×383×15 mm 3543ZF 460×383×15 mm 4343Z 460×460×15 mm 4343ZF 460×460×15 mm 4386Z 891×383×15 mm 6543Z 460×676×15 mm | | | | | | | | | | | | | | | | | | | | | Similar range<br>of<br>dimensions | | | | | Comparable<br>Properties | K170480 Models 3543A,<br>4343A, 2929A and A843B | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF,<br>3030Z, 3025Z, 3025ZF | Comparison<br>Results | | | | | | | | | | | | | | | | | | | | | | | | Pixels | 3543A: 2500 x 3052 (7.6 Million)<br>4343A: 3072 x 3072 (9.4 Million)<br>2929A: 2048 x 2048 (4.2 Million)<br>A843B: 7680 x 3072 (23.6 Million) | Model Pixels 3025Z 2048×1792 (3.7 Million) 3025ZF 3108×3956 (12.3 Million) 3030Z 2048x2048 (4.2 Million) 3543Z 2500×3052 (7.6 Million) 3543ZF 3534×4302 (15.2 Million) 4343Z 3072x3072 (9.4 Million) 4343ZF 4302x4302 (18.5 Million) 4386Z 3072×6144 (18.9 Million) 6543Z 4608×3072 (14.2 Million) | | | | | | | | | | | | | | | | | | | | | | Similar range | | | 2929A: 316 x 316 x 15 mm<br>A843B: 1120 x 465 x 20 mm | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Weights | 4343A: 4.3 kg (wireless, w/<br>batteries) 4.3 kg (wired, w/o<br>batteries)<br>3543A: 3.3 kg (wireless, w/<br>batteries) 2.9 kg (wired, w/o<br>batteries) | Model Weights 3025Z 1.7kg(wireless, w/ batteries)<br>1.5 kg(wired, w/o batteries) 3025ZF 1.7kg(wireless, w/ batteries)<br>1.5 kg(wired, w/o batteries) 3030Z 2.1 kg(wireless, w/ batteries)<br>1.9 kg(wired, w/o batteries) 3543Z 3.1 kg (wireless, w/ batteries)<br>2.7 kg (wired, w/o batteries) 3543ZF 3.1 kg (wireless, w/ batteries)<br>2.7 kg (wired, w/o batteries) 4343Z 3.6 kg (wireless, w/ batteries)<br>3.2 kg (wired, w/o batteries) 4343ZF 3.6 kg (wireless, w/ batteries)<br>3.2 kg (wired, w/o batteries) 4386Z 3.7kg(wireless, w/ batteries)<br>3.4kg(wired, w/o batteries) 6543Z 7.5kg (wireless, w/ batteries)<br>7.0kg(wired, w/o batteries) | | | | | | | | | | | | | | | | | | | | | Similar range | | | | | Interface | Wired: Gigabit Ethernet (1000Base-T)<br>Wireless: IEEE802.11ac, backward compatible | Wired: Gigabit Ethernet (1000Base-T)<br>Wireless: IEEE802.11ac, backward compatible | SAME | | | | | | | | | | | | | | | | | | | | | | | | Power Source | AC Line and/or<br>Rechargeable Lithium<br>Battery | AC Line and/or Rechargeable Lithium Battery | SAME | | | | | | | | | | | | | | | | | | | | | | | | Electrical safety and<br>EMC | Electrical Safety per IEC<br>60601-1 and EMC per<br>IEC 60601-1-2 as well as<br>IEEE 802.11ac.<br>Meets FCC requirements. | Electrical Safety per IEC 60601-1 and EMC per<br>IEC 60601-1-2 as well as IEEE 802.11ac.<br>Meets FCC requirements. | SAME | | | | | | | | | | | | | | | | | | | | | | | Standards | Same as below | See below | SAME | | | | | | | | | | | | | | | | | | | | | | | | Software Related | | | | | | | | | | | | | | | | | | | | | | | | | | | 2929A: 1.8 kg (wireless, w/<br>batteries) 1.5 kg (wired, w/o<br>batteries) | Software | | Outputs a DICOM image | Outputs a DICOM image | SAME | | | | | | | | | | | | | | | | | | | | | | A843B: 11.6 kg (wireless, w/<br>batteries) 10.9 kg (wired, w/o<br>batteries) | SW Name | | PZDR | PZDR | SAME | | | | | | | | | | | | | | | | | | | | | | | DICOM | | Yes | Yes | SAME | | | | | | | | | | | | | | | | | | | | | | DICOM Image<br>Transmission | Yes | Yes | SAME | | | | | | | | | | | | | | | | | | | | | | | | Image Acquisition<br>Interface | Yes | Yes | SAME | | | | | | | | | | | | | | | | | | | | | | | | Patient Body Part<br>Selection | Yes | Yes | SAME | | | | | | | | | | | | | | | | | | | | | | | | Image Processing | Yes | Yes | SAME | | | | | | | | | | | | | | | | | | | | | | | | Basic Image Editing<br>and Marking (pan,<br>zooming,<br>window/level<br>adjusting, text<br>marking) | Yes | Yes | SAME | | | | | | | | | | | | | | | | | | | | | | | | Image Browsing | Yes | Yes | SAME | | | | | | | | | | | | | | | | | | | | | | | {7}------------------------------------------------ {8}------------------------------------------------ | Comparable<br>Properties | K170480 Models 3543A,<br>4343A, 2929A and A843B | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF,<br>3030Z, 3025Z, 3025ZF | Comparison<br>Results | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------|-----------------------| | Patient Registration<br>and Management | Yes | Yes | SAME | | Local registration of<br>patient information | Yes | Yes | SAME | | Quick registration | Yes | Yes | SAME | | Checking/modification<br>of patient's<br>information | Yes | Yes | SAME | | Image acquisition<br>interface | Yes | Yes | SAME | | Deletion of record | Yes | Yes | SAME | | Image processing<br>parameter setting | Yes | Yes | SAME | | Image browsing<br>(Zooming, Marker,<br>Text, Window/Width<br>Adjustment, Moving,<br>ROI, Clipping,<br>Rotation, | Yes | Yes | SAME | | Dicom image<br>transmission | Yes | Yes | SAME | | Image exporting to CD | Yes | Yes | SAME | | Image printing (w/<br>printer setting) | Yes | Yes | SAME | | System management<br>(detector selection,<br>storage setting) | Yes | Yes | SAME | | Management of<br>inspection (Patient<br>size selection of large,<br>medium, thin,<br>children; patient<br>position of standing or<br>lying; patient imaging<br>body part) | Yes | Yes | SAME | | Setting of image<br>processing methods<br>(strong/medium/soft) | Yes | Yes | SAME | | Option for image<br>display (position, text<br>information, etc.) | Yes | Yes | SAME | | System logout | Yes | Yes | SAME | Non clinical testing: Testing was performed successfully according to the following standards: {9}------------------------------------------------ | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard | |----------------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI/AAMI | ANSI/AAMI ES60601-1: 2005<br>+C1:2009 +A2:2020<br>+A1:3012 | Medical Electrical Equipment Part1: General Requirements For Basic<br>Safety And Essential Performance | | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: General Requirements For Basic Safety<br>And Essential Performance Collateral Standard: Electromagnetic<br>Disturbances Requirements And Tests | The AC to DC power supply is UL Listed as a medical grade power supply. In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals. Since the three new digital receptor panels have not had previous FDA clearance, testing was performed according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff. # 7. Clinical testing. Not required for a determination of substantial equivalence. # 8. Substantial Equivalence Discussion. These updated digital x-ray receptor panels and software perform the same functions using the same technological methods to produce diagnostic x-ray images as the predicate. In all material aspects, the new panel models and software are substantially equivalent to each other. ## 9. Substantial Equivalence Conclusion: After analyzing bench test results, and clinical evaluation, it is the conclusion of PZMEDICAL that the new models of digital x-ray imaging panels are as safe and effective as the predicate devices, have few technological differences, and has the same indications for use, thus rendering them substantially equivalent to the predicate device.