A-SCAN PLUS CONNECT

{0}------------------------------------------------ K123349 Page 1-1 Image /page/0/Picture/2 description: The image shows a logo with the word "ACCUTOME" in bold, sans-serif font at the bottom. Above the word is a circular design with a stylized number "4" inside. The number is formed by geometric shapes, with a triangle at the top and a trapezoid at the bottom, creating a modern and abstract look. ## JAN 2 9 2013 l # 510(k) SUMMARY: A-Scan Plus Connect Applicant: Address: Contact Person: Preparation Date: Revision Date: Trade Name: Common Name: Classification Name: Telephone: Accutome, Inc. Note: Accutome Ultrasound, Inc. (listed as the manufacturer for the predicate device) is a wholly owned subsidiary of Accutome, Inc. and is located in the same facility. Accutome, Inc. is in the process of moving all device listings to the Accutome, Inc. name only. 3222 Phoenixville Pike Malvern, PA 19355 Adam Pickholtz Manager QA/QC (610) 889-0200 (610) 889-3233 Fax October 26, 2012 December 5, 2012 A-Scan Plus Connect Biometer System, Imaging, Pulsed Echo, Ultrasonic (21 CFR 892.1560, Product Code: IYO) Diagnostic Ultrasound Transducer (21 CFR 892.1570, Product Code: ITX) Legally Marketed Predicate Devices: Accusonic A-Scan (K032956) *There have been no prior FDA submissions for the A-Scan Plus Connect. Description of the Device: The Accutome A-Scan Plus Connect device is designed as a biometer, which uses pulsed echo ultrasound to measure the Accutome, Inc. Fax: 610-889-3233 Page 1 of 5 3222 Phoenixville Pike Malvern, PA 19355 Email: eyeopener@accutome.com Phone: 610-889-0200 www.accutome.com {1}------------------------------------------------ axial length, and the location of other structures of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a one-dimensional display of returning pulse echoes, with positive peaks to indicate the location of ocular structures. The distance between peaks can be measured. Indications for Use: This instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery. #### Comparison of Technological Characteristics to the predicate device: All of the critical functions of the A-scan Plus Connect are calculated in exactly the same manner as in the predicate device Accusonic A-Scan. The probe used with the A-Scan Plus Connect is exactly the same as the probe used on the Accusonic A-Scan. The software algorithms for clinically critical functions, i.e. to process ultrasound measurements and calculate intraocular lens parameters remain exactly the same as in the predicate device. The new A-Scan Plus Connect model uses the personal computer as the main computing vehicle and display instead of the dedicated computer/display of the predicate device. The software modifications in the Connect model are those necessary to interface the processing, data storage, display, and printing capabilities of the personal computer. The A-Scan Plus connect control unit is an interface between the ultrasonic probe and a personal computer. It consists of a microprocessor based printed circuit board, with USB connections, enclosed in a plastic case. The energy source for the A-Scan Plus Connect is USB power from the personal computer instead of the AC to DC adapter used to power the predicate device. The chemical composition of patient contact materials is identical to that of the predicate device. Accutome, Inc. Fax: 610-889-3233 Page 2 of 5 3222 Phoenixville Pike Malvern, PA 19355 Email: evenpenen@accutome.com Phone: 610-889-0200 www.accutome.com {2}------------------------------------------------ #### Standards Testing: #### EN 60601-1 Medical Electronic Equipment Part 1: General Requirements for Safety Both this device and the predicate were tested to, and found to be compliant with EN 60601-1. #### EN 60601-1-2 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests Both this device and the predicate were tested to, and found to be compliant with EN 60601-1-2. #### IEC 60601-2-37 - Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment Acertara Acoustic Laboratories evaluated the device in May and June 2012 in accordance with IEC 60601-2-37:2007 and Section 1.6.1 of the September 2008 FDA Guidance Document. Sonora Medical Systems (now Acertara Acoustic Laboratories) evaluated the predicate device in March 2002 in accordance with Section 4.6.1 of the September 1997 FDA Guidance Document. #### EN/ISO 10993 - Biological Evaluation of Medical Devices Compliance per Toxikon Test Reports 03-1518-G1 dated 03 April 2003, 03-1518-G2 dated 16 May 2003, and 03-1518-G3 dated 18 April 2003. The same probe is used with this device as with the predicate device; the materials have not changed. #### Verification Testing: #### Physical Accuracy Test This test compares the distance measured ultrasonically by the A-Scan Plus Connect and the physical distance measured by a mechanical dial indicator. The test results for both the A-Scan Plus Connect model and the predicate device were well within the 0.1mm acceptance criteria. #### Results: Both the A-scan Plus Connect model and the predicate device were well within the 0.1mm acceptance criteria. #### Data Comparison Test: Accusonic A-Scan (predicate) vs. A-Scan Plus Connect The objective of this test is to compare critical parameter results between the two devices under conditions of the same input test fixture and values. Accutome, Inc. Fax: 610-889-3233 Page 3 of 5 {3}------------------------------------------------ #### Results: All of the data met the established acceptance criteria: -Ultrasound measurements for all eye types shall be within 0.05mm -IOL calculation results for all formulas shall be within one decimal place #### Validation Testing: #### Internal Validation Tests A test plan was developed to evaluate proper operation and usability for all device modes/options. The plan consisted of 83(as of 12/5/12) specific evaluations of characteristics of the device, most of which required multiple actions or observations on the part of the user. #### Results: All operations and features were fully functional. There were no errors or deficiencies in the patient information. The usability was judged to be superior to the predicate device. #### External Validation Tests A checklist was developed which requests quantified critique regarding the safety, functionality and usability of the device via 11 specific questions. A Rating Scale from 1 to 5 was used with: 5 = best, very user friendly, no problems; and 1 = not acceptable, very unfriendly, significant problem that must be corrected. #### Results: The device was evaluated on 29 different patients at 3 different locations by 3 different experienced technicians/ophthalmologists. One of the users had detailed experience with the predicate device and two with a competitive biometer. Safety was ranked 5 by every user. The average rating for the 9 specific attributes enumerated was 4.8. The "Overall Rating" of the device was 5 by all users. There were no ratings of 1 or 2 in any of the tests. {4}------------------------------------------------ #### Validation Tests Summary The internal and external validation tests demonstrate that there are no known safety issues with the A-Scan Plus Connect device. The tests further demonstrate that there are no significant functionality issues and that the usability of the device is superior to that of the predicate device. #### Conclusion: The positive results of the testing above, along with the risk analysis performed, demonstrate that the A-Scan Plus Connect is at least as safe and as effective, and has improved usability, when compared to the predicate device. Accutome, Inc. Fax: 610-889-3233 Page 5 of 5 .... {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 February 13, 2013 Accutome, Inc c/o Adam Pickholtz Regulatory Manager 3222 Phoenixville Pike MALVERN PA 19355 Re: K123349 Trade/Device Name: A-Scan Plus Connect Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: January 17, 2013 Received: January 22, 2013 Dear Mr. Pickholtz: This letter corrects our substantially equivalent letter of January 29, 2013. 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. This determination of substantial equivalence applies to the following transducer intended for use with the A-Scan Plus Connect, as described in your premarket notification: #### 10 mhz 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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. {6}------------------------------------------------ Page 2 - Mr. Pickholtz 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. If you have any questions regarding the content of this letter, please contact Robert Ochs at (301) 796-6661. Sincerely yours, Sean M. Boyd -\$_{for}\$ Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use Page 1-1 510(k) Number (if known): K123349 Device Name: A-scan Plus Connect Indications for Use: This instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery. 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 In Vitro Diagnostics and Radiological Health (OIR) # Sean M. Boyd -S (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)_ K123349 Page 1 of __1_________________________________________________________________________________________________________________________________________________________________ {8}------------------------------------------------ ### Tab 2- IFU Tables ## System: Accutome A-Scan Plus Connect | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | A | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | P | | | | | | | | Fetal Imaging &<br>Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal<br>(Conventional) | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | Vessel | Other (Specify) | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: B-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging Image /page/8/Picture/5 description: The image shows the name "Sean M. Boyd" in bold, black font. Below the name, in smaller font, is the text "(Division Sign Off)". To the right of the name is the letter "S". Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K123349 510(k) {9}------------------------------------------------ #### Transducer: 10 mhz | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | A | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | P | | | | | | | | Fetal Imaging &<br>Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal<br>(Conventional) | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | Vessel | Other (Specify) | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: B-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging # Sean M. Boyd -S (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Heattr KI23349 510((4)