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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies mentioned for the AccuTip Cover, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Verification Testing	Product meets all proposed design inputs and outputs.	"The AccuTip cover design met all of the proposed design inputs and outputs."
Comparison Testing	Tonometer readings with AccuTip Cover are within proposed acceptance criteria compared to predicate.	"Readings with the AccuTip cover as compared to readings with the predicate were within the proposed acceptance criteria."
Validation Testing	All features are fully functional and meet specified intended use and method of application.	"All features were fully functional and met the specified intended use and method of application."
High Level Disinfection	Samples meet pre-determined acceptance criteria for bioburden and sterility assurance level.	"The samples met the pre-determined acceptance criteria." (Specific numerical criteria for bioburden or sterility assurance level are not detailed in the provided document, but it confirms the criteria were met).
Aging Testing	Aged samples meet pre-determined acceptance criteria for integrity and other possible defects.	"The aged samples met the pre-determined acceptance criteria." (Specific integrity or defect criteria are not detailed, but the document confirms the criteria were met after a 1-year accelerated aging study).
Biocompatibility	Compliance with EN/ISO 10993 and FDA G95-1 guidelines.	"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" (Implies compliance was achieved).

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not specify the sample size used for the test set in any of the studies (Verification, Comparison, Validation, Disinfection, or Aging testing).

The document does not explicitly state the country of origin of the data. Given Accutome, Inc. is located in Malvern, PA, USA, and the FDA correspondence, it's highly probable the studies were conducted in the USA.

The studies described are prospective in nature, as they involve testing the AccuTip Cover under various conditions to demonstrate its performance and safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

The document does not mention the use of external experts or the establishment of "ground truth" in the context of expert consensus for any of the studies. The evaluation criteria appear to be based on internal design specifications, historical predicate device performance, and established standards.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. The evaluations appear to be straightforward comparisons against predetermined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices or AI-assisted systems, which the AccuTip Cover, a physical tonometer tip cover, is not. The document does not discuss AI or human reader improvement.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

A standalone study was not done. The AccuTip Cover is a passive physical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" for the studies performed for the AccuTip Cover is derived from different sources depending on the test:

Verification Testing: Internal design inputs and outputs.
Comparison Test: Performance of the legally marketed predicate device (Ocu-Lab Ocu-Film Tip Cover).
Validation Testing: Specified intended use and method of application.
High Level Disinfection Validation: Pre-determined acceptance criteria for bioburden and sterility assurance level, likely based on established microbiological standards.
Aging Testing: Pre-determined acceptance criteria for integrity and defects, likely based on material science and device longevity standards.
Biocompatibility: Compliance with established international (EN/ISO 10993) and national (FDA G95-1) biocompatibility standards.

In essence, the "ground truth" is a combination of engineering specifications, performance relative to a predicate, and compliance with recognized industry standards.

8. The Sample Size for the Training Set:

There is no mention of a "training set" in the document. This concept is applicable to machine learning or AI models, which are not relevant to the AccuTip Cover.

9. How the Ground Truth for the Training Set was Established:

As there is no training set, this question is not applicable.

Summary

{0}------------------------------------------------

K132549

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 PikeMalvern, PA 19355
Contact Person:	Adam PickholtzManager 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 MarketedPredicate Devices:	Ocu-Lab Ocu-Film Tip Cover (K882750)
Description of the Device:	The AccuTip Cover is a non-sterile, sanitized, single use latexdisposable. It is used to cover the tip of a handheld tonometer.
Indications for Use:	An AccuTip Cover is applied over the tip of a handheldtonometer prior to performing tonometry. The tip cover isused 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'

Regulation Number and Section

§ 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.