PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT

{0}------------------------------------------------ # JUL = 2 2002 1021984 Attachment A-2 510(k) Summary {1}------------------------------------------------ ## 510(k) Summary for the Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System #### 1. SPONSOR Inceptio Medical Technologies, L.C. 1401 N. Hwy 89, Suite 220 Farmington, Utah 84025 Contact Person: Bradley J. Stringer Telephone: 801-447-7000 Fax: 801-447-7400 Date Prepared: May 30, 2002 #### 2. Device Name | Proprietary Name: | PunctSURE® Ultrasound Vascular Imaging System | |----------------------|-----------------------------------------------------------------------| | Common/Usual Name: | Diagnostic pulsed Doppler imaging system<br>Pulse echo imaging system | | Classification Name: | Diagnostic ultrasound system | #### 3. PREDICATE DEVICES Site~Rite 3 (K993624) #### 4. DEVICE DESCRIPTION The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System with associated transducer and accessories is designed and manufactured to provide hands-free ultrasound vascular imaging (simultaneous transverse and longitudinal views) for percutaneous vascular punctures (needle placement and vessel catheterization). The PunctSURE® System consists of three major subsystems: (1) the Transducer and Cable, (2) the Dual Image Monitor, and (3) the Sterile Vascular Imaging Procedure Kit. The sterile, single use, and disposable PunctSURE® Vascular Imaging Procedure Kit contains products used for the diagnostic procedure (magnetic laminate, acoustic coupling gel, sheath, snap ring, transducer cover, gauze sponges, and cotton swabs). {2}------------------------------------------------ #### 5. INTENDED USE The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit are indicated for real-time imaging of selected blood vessels and nearby anatomic structures before and during percutaneous procedures, ultrasonic guidance for needle placement and vessel catheterization in a sterile environment, and Doppler confirmation of directional blood flow. #### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE Inceptio Medical Technologies, L.C. claims equivalence of the PunctSURE® Ultrasound Vascular Imaging System to the Site~Rite 3 based on intended use, technological, and operational characteristics. A side-by-side comparison of the PunctSURE® System and the Site~Rite 3 is provided in the table below. ### Side-by-Side Comparison of the Inceptio PunctSURE® Ultrasound Vascular Imaging System with the Dymax Site~Rite 3 | Characteristic | Inceptio<br>PunctSURE® | Site~Rite 3<br>Dymax<br>K993624 | |--------------------------------------------------------------|----------------------------------------------------|------------------------------------------| | Indications for Use:<br>Vascular imaging for needle guidance | Yes | Yes | | Contraindication | Implanted pacemaker | None specified | | Fundamental Technological Characteristics | | | | Fundamental Technology | Pulsed echo ultrasound | Pulsed echo ultrasound | | Real time | Yes | Yes | | B-Mode | Yes | Yes | | Digital | Yes | Yes | | Software-controlled | Yes | Yes | | Design and Operational Characteristics | | | | Hands free visualization | Yes | No | | Doppler confirmation of directional blood flow | Yes | No | | Probes | Image element: 7.5 MHz<br>Doppler element: 5.0 MHz | 9.0 MHz<br>7.5 MHz<br>5.9 MHz<br>3.5 MHz | | Sterilizable probe (transducer) | No | No | | Probe disinfection instructions provided | Yes | Yes | {3}------------------------------------------------ ### Side-by-Side Comparison of the Inceptio PunctSURE® Ultrasound Vascular Imaging System with the Dymax Site~Rite 3 (Continued) | Characteristic | Inceptio<br>PunctSURE® | Site-Rite 3<br>Dymax<br>K993624 | |--------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | Focal Depth | Imaging element: 20 mm ± 5 mm<br>Doppler element: 35 mm ± 5 mm | Min: 0.5 cm (9.0 MHz probe)<br>Max: 18 cm depth (3.5 MHz probe) | | Sector angle | N/A | 9.0 and 7.5 MHz probes: 26 degrees<br>3.5 MHz: 75 degrees | | Views | Transverse and Longitudinal | Transverse or Longitudinal | | Dual image monitor | Yes | No | | Screen size | 12.1" diagonal LCD | 4 ½" diagonal CRT | | Freeze frame | No | Yes | | Video output | No | Yes | | Battery powered | No | Yes | | Battery time | Not applicable | 2 hour run<br>5 hour recharge | | Battery type | Not applicable | Nickel metal hydride | | AC powered | Yes | Yes | | Portable System | Yes | Yes | | Sterile kit | Accessories<br>Yes | Yes (from other source) | | Kit contents | 4 x 4 gauze<br>Adhesive laminate<br>Acoustic gel<br>Probe cover (sheath)<br>Magnetic cover<br>Snap ring<br>Prep tray<br>CSR wrap | Needle guide<br>Acoustic gel<br>Probe cover | #### 7. PERFORMANCE TESTING The PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit were tested according to and demonstrated in compliance with requirements set forth in FDA Guidance {4}------------------------------------------------ "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"(1997) including the following, FDArecognized, voluntary standards: - Safety of Medical Electrical Equipment Part 2: "Particular Requirements . for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment" - EN60601-1 Medical Electrical Equipment Part 1, General Requirements . for Safety (1988), Amendment 1 (1991), Amendment 2 (1995) - UL2601-1. Second Edition . - CAN/CSA-C22.2 No. 601-1-M90 ● - IEC 60601-1-1 Medical Electrical Equipment Part 1-1: General . Requirements for Safety, Collateral Standard: Safety requirements for medical electrical systems (2000) - IEC 60601-1-4 Medical Electrical Equipment Part 1-1: General . Requirements for Safety, Collateral Standard: Programmable electrical medical systems (2000) - IEC 60601-2-37 Medical Electrical Equipment Part 2-37: Particular . Requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (2001) - Electromagnetic Immunity (IEC 60601-1-2, §36.202) Medical electrical ● equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests - Electromagnetic Emissions [IEC 60601-1-2: 2001, §36.201/CISPR 11: . 1997, Class A; IEC 61000-3-2: Electromagnetic compatibility (EMC) -Part 3-2: Limits - Limits for harmonic current emissions (equipment input current <= 16A per phase)(1995); IEC 61000-3-3: Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection (1995)]. In addition, verification and validation testing demonstrates that the System fulfills performance specifications. {5}------------------------------------------------ Image /page/5/Picture/2 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 emblem featuring a stylized image of three human profiles facing to the right, with three abstract shapes above them. JUL = 2 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Inceptio Medical Technologies, L.C. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298 Re: K021984 Trade Name: PunctSURER Ultrasound Vascular Imaging System, PunctSURE® Vascular Imaging Procedure Kit Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: June 17, 2002 Received: June 18, 2002 Dear Mr. Mosenkis: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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. This determination of substantial equivalence applies to the following transducers intended for use with the PunctSURE Ultrasound Vascular Imaging System, PunctSURES Vascular Imaging Procedure Kit, as described in your premarket notification: Transducer Model Number Ultrasonic Piezoelectric Transducer (Part #: IN00001) {6}------------------------------------------------ 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 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. This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212. Sincerely vours. Nancyc brogdon Nancy C. Brdedon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ ### Diagnostic Ultrasound Indications for Use Form 510(k) Number (if known): KOJ/984 Device Name: Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and Vascular Imaging Procedure Kit Diagnostic ultrasound imaging and blood flow directional analysis as follows: Intended Use: | Clinical<br>Application | Mode of Operation | | | | | | | | | | |---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(Specify) | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small organ<br>(Specify) | | | | | | | | | | | | Neonatal cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vascular | | N | | N | | N | | | | | | Laparoscopic | | | | | | | | | | | | Musculoskeletal<br>Conventional | | | | | | | | | | | | Musculoskeletal<br>Superficial | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | N=New Indication; P=previously cleared by FDA; E=added under Appendix E Additional Comments: Indications for Use: The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit are indicated for real-time imaging of selected blood vessels and nearby anatomic structures before and during percutaneous procedures, ultrasonic guidance for needle placement and vessel catheterization in a sterile environment, and Doppler confirmation of directional blood flow. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Slogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K021984 Prescription Use (Per 21 CFR 801.109) Response to Abbreviated 510(k) June 12, 2002 Inceptio Medical PunctSURE® Ultrasound Vascular Imaging System Revised Page 2-1 {8}------------------------------------------------ ### Diagnostic Ultrasound Indications for Use Form 510(k) Number (if known): K021984 Device Name: Inceptio Medical Technologies, L.C. PunctSÜRE® Ultrasound Transducer Diagnostic ultrasound imaging and blood flow directional analysis as follows: Intended Use: | Clinical | Mode of Operation | | | | | | | | | | |---------------------------------|-------------------|---|---|-----|-----|---------|-----------|----------|-----------|-----------| | Application | A | B | M | PWD | CWD | Color | Amplitude | Color | Combined | Other | | | | | | | | Doppler | Doppler | Velocity | (Specify) | (Specify) | | | | | | | | | | Imaging | | | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(Specify) | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small organ<br>(Specify) | | | | | | | | | | | | Neonatal cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vascular | | N | | N | | N | | | | | | Laparoscopic | | | | | | | | | | | | Musculoskeletal<br>Conventional | | | | | | | | | | | | Musculoskeletal<br>Superficial | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | N=New Indication; P=previously cleared by FDA; E=added under Appendix E ### Additional Comments: Indications for Use: The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit are indicated for real-time imaging of selected blood vessels and nearby anatomic structures before and during percutaneous procedures, ultrasonic guidance for needle placement and vessel catheterization in a sterile environment, and Doppler confirmation of directional blood flow. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C Brogdon Radiological Devices 10(k) Number K021984 O Prescription Use (Per 21 CFR 801.109) Response to Abbreviated 510(k) June 12, 2002 Inceptio Medical PunctSURE® Ultrasound Vascular Imaging System Revised Page 2-2