(252 days)
No
The device is a simple disposable cover for a tonometer tip and the summary contains no mention of AI or ML.
No
The AccuTip Cover is a protective barrier for an instrument and the patient, not a device that directly treats, prevents, or diagnoses a disease or condition. Its function is to cover the tip of a tonometer, which is a diagnostic device used to measure intraocular pressure.
No
The device, AccuTip Cover, is a disposable tip cover for a tonometer. While it is used with a tonometer, which is a diagnostic device for measuring intraocular pressure, the AccuTip Cover itself is not performing the diagnostic function; it is a protective accessory. Its intended use is to protect the patient's eye and the instrument tip during tonometry.
No
The device description clearly states it is a "non-sterile, sanitized, single use latex disposable," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover the tip of a handheld tonometer for protection of the patient's eye and the instrument tip during tonometry (measuring intraocular pressure). This is a physical barrier and protective function.
- Device Description: It's described as a non-sterile, sanitized, single-use latex disposable cover.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic test or provide information about a patient's health condition based on in vitro examination of specimens. It's an accessory used during a diagnostic procedure (tonometry), but it's not the diagnostic device itself.
- No Mention of Specimens: There is no mention of the device being used with biological specimens (blood, urine, tissue, etc.), which is a key characteristic of IVDs.
In summary, the AccuTip Cover is a medical device accessory used to facilitate a diagnostic procedure (tonometry), but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
An AccuTip Cover is applied over the tip of a handheld tonometer prior to performing tonometry. The tip cover is used for protection of the patient's eye and the instrument tip.
The AccuTip Cover is intended to be used in conjunction with a handheld tonometer by trained individuals experienced in taking intraocular pressure measurements.
Product codes
HKY
Device Description
The AccuTip Cover is a non-sterile, sanitized, single use latex disposable. It is used to cover the tip of a handheld tonometer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained individuals experienced in taking intraocular pressure measurements.
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
An internal design verification testing was conducted on the AccuTip cover for verification that the product met all the proposed design inputs and outputs.
A comparison test was conducted to compare tonometer readings taken with an AccuTip cover and readings taken with the predicate device.
An internal validation plan was developed and tested for the AccuTip Cover to assure that the product meets the specified intended use and method of application.
A determination of bioburden was conducted on AccuTip cover samples.
AccuTip Cover samples were irradiated via a validated method and incubated for a 1 year accelerated aging study. The samples were then tested for integrity and other possible defects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification Testing: Internal design verification testing was conducted on the AccuTip cover for verification that the product met all the proposed design inputs and outputs. Results: The AccuTip cover design met all of the proposed design inputs and outputs.
Comparison Test: A comparison test was conducted to compare tonometer readings taken with an AccuTip cover and readings taken with the predicate device. Results: Readings with the AccuTip cover as compared to readings with the predicate were within the proposed acceptance criteria.
Validation Testing: An internal validation plan was developed and tested for the AccuTip Cover to assure that the product meets the specified intended use and method of application. Results: All features were fully functional and met the specified intended use and method of application.
High Level Disinfection Validation: A determination of bioburden was conducted on AccuTip cover samples. Samples were then validated to the appropriate sterility assurance level and results were documented. Results: The samples met the pre-determined acceptance criteria.
Aging Testing: AccuTip Cover samples were irradiated via a validated method and incubated for a 1 year accelerated aging study. The samples were then tested for integrity and other possible defects. Results: The aged samples met the pre-determined acceptance criteria.
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
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.
0
Page 3-1
APR 2 3 2014
Image /page/0/Picture/9 description: The image shows a logo for a company called ACCUTOME. The logo consists of a stylized graphic above the company name. The graphic is a black circle with a white shape inside that resembles a stylized number 4. The text "ACCUTOME" is in a bold, sans-serif font.
510(k) SUMMARY: AccuTip Cover
| Applicant: | Accutome, Inc. |
|---|---|
| Address: | 3222 Phoenixville Pike |
| Malvern, PA 19355 | |
| Contact Person: | Adam Pickholtz |
| Manager QA/QC | |
| Telephone: | (610) 889-0200 |
| (610) 889-3233 Fax | |
| Preparation Date: | July 30, 2013 |
| Trade Name: | AccuTip Cover |
| Common Name: | Tonometer tip cover |
| Classification Name: | Tonometer and accessories |
| (21 CFR 886.1930, Product Code: HKY) | |
| Legally Marketed | |
| Predicate Devices: | Ocu-Lab Ocu-Film Tip Cover (K882750) |
| Description of the Device: | The AccuTip Cover is a non-sterile, sanitized, single use latex |
| disposable. It is used to cover the tip of a handheld tonometer. | |
| Indications for Use: | An AccuTip Cover is applied over the tip of a handheld |
| tonometer prior to performing tonometry. The tip cover is | |
| used for protection of the patient's eye and the instrument tip. |
1 Accutome, Inc. Fax: 610-889-3233 Page 1 of 3
3222 Phoenixville Pike Malvern, PA 19355 Email: eyeopener@accutome.com
Phone: 610-889-0200 www.accutome.com
1
Intended Use:
The AccuTip Cover is intended to be used in conjunction with a handheld tonometer by trained individuals experienced in taking intraocular pressure measurements.
Comparison of Technological Characteristics to the predicate device:
Standards Testing:
Verification Testing:
Both the AccuTip Cover and the Ocu-FilmTip Cover are shaped to cover the tip of a handheld tonometer, and are used to protect patients from cross contamination and to protect the tonometer sensors from dust or fluids. The two finished products have been tested to the same biocompatibility standards and are both made of natural rubber latex. Both the AccuTip Cover and the Ocu-Film Tip Cover are sanitized through the use of gamma irradiation.
EN/ISO 10993 - Biological Evaluation of Medical Devices Compliance per Toxicon reports 13-01358-G1, 13-01358-G2, and 13-01358-G3.
FDA G95-1, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
Internal design verification testing was conducted on the AccuTip cover for verification that the product met all the proposed design inputs and outputs.
Results: The AccuTip cover design met all of the proposed design inputs and outputs.
Comparison Test:
A comparison test was conducted to compare tonometer readings taken with an AccuTip cover and readings taken with the predicate device.
Results:
Readings with the AccuTip cover as compared to readings with the predicate were within the proposed acceptance criteria.
Accutome, Inc. Fax: 610-889-3233 Page 2 of 3
3222 Phoenixville Pike Malvern, PA 19355 Email: eveopener@accutome.com
Phone: 610-889-0200 www.accutome.com
2
Validation Testing:
An internal validation plan was developed and tested for the AccuTip Cover to assure that the product meets the specified intended use and method of application.
Results:
· All features were fully functional and met the specified intended use and method of application.
High Level Disinfection Validation:
A determination of bioburden was conducted on AccuTip cover samples. Samples were then validated to the appropriate sterility assurance level and results were documented.
Results:
The samples met the pre-determined acceptance criteria.
Aging Testing:
AccuTip Cover samples were irradiated via a validated method and incubated for a 1 year accelerated aging study. The samples were then tested for integrity and other possible defects.
Results:
The aged samples met the pre-determined acceptance criteria.
Accutome, Inc. Fax: 610-889-3233 Page 3 of 3
3222 Phoenixville Pike Malvern, PA 19355 Email: eyeopener@accutome.com
Phone: 610-889-0200 www.accutome.com
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
April 23, 2014
Accutome, Inc. Mr. Adam Pickholtz Manager OA/QC 3222 Phoenixville Pike Malvern, PA 19355
Re: K132549
Trade Name: AccuTip Cover Regulation Number: 21 CFR 886.1930 Regulation Name: Manual tonometer & accessories Regulatory Class: Class II Product Code: HKY Dated: April 7, 2014 Received: April 10, 2014
Dear Mr. Pickholtz:
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 10 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.
: 上海:
11 13
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
4
Page 2 - Mr. Adam Pickholtz
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); 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education 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,
Deborah L. Falls -S
Malvina B. Eydelman, MD for
Director
.. :. .
Division of Ophthalmic and Ear, Nose and Throat Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Device Name:
AccuTip Cover
Indications for Use:
An AccuTip Cover is applied over the tip of a handheld tonometer prior to performing tonometry. The tip cover is used for protection of the patient's eye and the instrument tip.
Prescription Use____ X (Part 21 CFR 801 Subpart D)
Over-The Counter Use_ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KI33549
Andrew Yang -S 2014.04.18 16:36:47 -04'00'