(85 days)
The ACCU-CHEK® Performa system is designed to quantitatively measure the concentration of The recor crimites I visual in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
The ACCU-CHEK Performa is a blood glucose testing product and based on the ACCU-CHEK Aviva System. The ACCU-CHEK Performa system maintains performance characteristics with ACCU-CHEK Aviva. The ACCU-CHEK Performa system is comprised of: The ACCU-CHEK Performa blood glucose monitor, The ACCU-CHEK Performa blood glucose test strip, The ACCU-CHEK Performa Control Solutions. The test principle is: Blood from the test site works with the chemicals in the test strip to make a small electric current in the test strip. The meter reads the current and gives a blood glucose result.
This 510(k) summary for the ACCU-CHEK Performa System is very brief and primarily focuses on establishing substantial equivalence to the predicate device, the ACCU-CHEK Aviva System. It explicitly states that "All predetermined acceptance criteria were satisfied" and that the data "demonstrates that the ACCU-CHEK Performa is substantially equivalent to the predicate device." However, it does not provide detailed performance metrics, acceptance criteria values, or specific study designs beyond general statements.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment cannot be found in the provided text. The document relies on the assertion that performance characteristics are maintained and acceptance criteria were met, without disclosing the specifics.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| The document states "All predetermined acceptance criteria were satisfied" but does not define these criteria or provide specific performance metrics. | The document states the device "maintains performance characteristics with ACCU-CHEK Aviva" but does not quantify these characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned in the provided text.
- Data Provenance (Country of Origin): Not mentioned in the provided text.
- Retrospective or Prospective: Not mentioned in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This type of information is not relevant for a blood glucose monitoring system, which typically uses laboratory reference methods for ground truth, not expert consensus on images. The document does not mention experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Ground truth for blood glucose meters is established by comparison to a laboratory reference method, not by expert adjudication of interpretations.
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
- Not applicable. This is a blood glucose monitoring device, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. Blood glucose meters operate in a standalone manner, providing a quantitative result directly. The performance studies would have evaluated the accuracy of the device itself against a reference method. The phrase "Performance testing on the ACCU-CHEK Performa System demonstrated that the device meets the performance requirements for its intended use" indicates this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- While not explicitly stated, for a blood glucose monitoring system, the ground truth would typically be established using a laboratory reference method (e.g., a YSI glucose analyzer) to determine the true glucose concentration in blood samples.
8. The sample size for the training set
- Not mentioned. The document describes performance testing, which implies a test set, but does not detail any "training set" for an algorithm. While the device is "based on the ACCU-CHEK Aviva System," there's no mention of specific algorithm training data in this summary.
9. How the ground truth for the training set was established
- Not mentioned, as no training set details are provided.
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| 510(k) Summary | MAY 2 5 2007 |
|---|---|
| ---------------- | -------------- |
Introduction
According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence.
| 1) Submitter name, address, contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Scott ThielDate Prepared: February 27, 2007 |
|---|---|
| 2) Device name | Proprietary name: ACCU-CHEK Performa SystemClassification name: Glucose dehydrogenase, glucose test system(21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicate device | ACCU-CHEK Aviva System |
| 4) Device Description | The ACCU-CHEK Performa is a blood glucose testing product and based on the ACCU-CHEK Aviva System. The ACCU-CHEK Performa system maintains performance characteristics with ACCU-CHEK Aviva.The ACCU-CHEK Performa system is comprised of:The ACCU-CHEK Performa blood glucose monitorThe ACCU-CHEK Performa blood glucose test stripThe ACCU-CHEK Performa Control Solutions |
The test principle is:
Blood from the test site works with the chemicals in the test strip to make
a small electric current in the test strip. The meter reads the current and
gives a blood glucose result.
Continued on next page
510(k) Summary
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510(k) Summary, Continued
| 5) Intendeduse | The ACCU-CHEK Performa system is designed to quantitatively measurethe concentration of glucose for monitoring glucose in the home or inhealth care facilities. Testing sites include traditional fingertip site alongwith palm, forearm, upper arm, thigh, and calf.Professionals may use the test strips to test capillary, venous, arterial, andneonatal blood; home use is limited to capillary whole blood testing. |
|---|---|
| 6) Substantialequivalence | The Roche Diagnostics ACCU-CHEK Performa System is substantiallyequivalent to the current legally marketed ACCU-CHEK Aviva System. |
| 7) Datademonstratingsubstantialequivalence | Performance testing on the ACCU-CHEK Performa System demonstratedthat the device meets the performance requirements for its intended use.All predetermined acceptance criteria were satisfied. The datademonstrates that the ACCU-CHEK Performa is substantially equivalent tothe predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 5 2007
Mr. Scott Thiel, MBA, MT(ASCP) Regulatory Affairs Program Manager Regulatory Affairs Diabetes Care Indianapolis Office Roche Diagnostic Corp. 9115 Hague Rd. Indianapolis, IN 46256
K070585 Re:
Trade/Device Name: ACCU-CHEK® Performa System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: February 27, 2007 Received: March 1, 2007
Dear Mr. Thiel:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your becamined the device is substantially equivalent (for the indications forcronous above and normal to legally marketed predicate devices marketed in interstate for use build in the energency of 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.
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K070585 Attachment 3
Indications for Use
K070585 510(k) Number (if known):
ACCU-CHEK® Performa System Device Name:
Indications For Use:
The ACCU-CHEK® Performa system is designed to quantitatively measure the concentration of The recor crimites I visual in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
Prescription Use XX (Part 21 CFR 801 Subpart D)
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Over-The-Counter Use ___ XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.C.H
Division Sign-Off
Division Sign-Off
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Office of In Vitro Diagnostic Device
Evaluation and Safety
K070585
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.