(78 days)
Not Found
No
The description focuses on robotic guidance based on stereotactic exposures, not on AI/ML for image analysis or decision-making. There are no mentions of AI, ML, DNN, or image processing.
No
The device aids in the accurate positioning of a biopsy needle for diagnosis, rather than directly treating a medical condition.
No
Explanation: The device is described as an automatic needle guidance system that aids in the accurate positioning and penetration of a biopsy needle to a breast lesion. Its function is to facilitate the collection of tissue for biopsy, not to diagnose a condition itself. The process of analyzing the collected biopsy tissue would be a diagnostic step, not the function of this device.
No
The device description explicitly states it comprises a "robotic biopsy unit" and a "film read out and motor control evaluation unit," indicating significant hardware components.
Based on the provided information, the ROBOLITE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ROBOLITE's Function: The ROBOLITE is a needle guidance system used during a biopsy procedure. Its purpose is to accurately position a needle for tissue collection from the body. It does not perform any analysis or examination of the collected tissue sample itself.
The ROBOLITE is a medical device used in conjunction with a procedure that ultimately leads to an in vitro diagnostic test (the analysis of the collected tissue sample), but it is not the IVD device itself.
N/A
Intended Use / Indications for Use
The ABBOTT Advisor One-Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. The ABBOTT Advisor One-Step Pregnancy Test is an over-the counter in vitro test which can be used by the consumer to detect pregnancy as early as the first day of her missed period, using a direct urine stream sampling method. Some positive results appear as soon as three minutes, however, all results are confirmed when the Test Timer turns pink/red. The Test Timer will turn pink/red approximately 5 minutes after the urine has been added to the test device.
Product codes
Not Found
Device Description
The ABBOTT Advisor One-Step Pregnancy Test is an elongated device composed of two pieces of molded plastic which contain the internal test strip. The three openings on the device are the Urine Well, the Result Window and the Test Timer. The Result Window and the Test Timer are protected with a clear seal to prevent potential contamination caused by splashing urine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumer
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 862.2100 Calculator/data processing module for clinical use.
(a)
Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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JAN 2 4 1997
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SUMMARY OF SAFETY AND EFFECTIVENESS
effectiveness information is being This summary of safety and submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter :
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Box 2412, Ra'anana 43654, Shai - Syg Motion & Innovations Ltd., P.O. Israel Contact person: Jacob Gross Tel: +972.9.7413611 Fax: +972.9.7410662
Name of the Device: ROBOLITE
- substantially equivalent The ROBOLITE is Devices: to Predicate applicant Shai-Syg the Roboquide manufactured by the i s and ਰ development of the Roboguide.
- the Device: The ROBOLITE is an automatic needle Description of for accurate positioning of guidance system that provides means a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The ROBOLITE I S an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Robolite drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The ROBOLITE can be used for fine for core biopsy by using the reqular needle aspiration (FNA) or carrier with a biopsy gun. needle with either plain film with a The ROBOLITE can be used X-ray or digital camera.
Comparison of Technological Characteristics: The systems share almost all the same hardware and functional characteristics.
- the Robolite and the - The biopsy unit of Roboguide are based on exactly the same design and construction.
- stereotaxis to identify the location of a Both units employ i breast lesion and then drives a needle carrier along axes to a point that allows accurate placement three coordinate the biopsy needle point into the lesion. of
- Both units have means for compressing and immobilizing the breast during the procedure.
- safety mechanisms to assure no movement of the Both units employ ı needle carrier during biopsy needle injection.
- have exactly the same evaluation unit with same drive, - Both units control and software units.
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[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Trade Name | ABBOTT Advisor One-Step Pregnancy Test |
|---|---|
| Common Name | Consumer Use Home Pregnancy Test |
| Classification Name | Human Chorionic Gonadotropin (hCG) |
| Test System | |
| Device Classification | Class II |
| Predicate Device Name | FactPLUS® One Step Pregnancy Test |
| (K962521) |
The following information as presented in the 510(k) Notification for the ABBOTT Advisor One-Step Pregnancy Test constitutes data supporting a substantially equivalent determination.
Intended Use
The ABBOTT Advisor One-Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Indications
The ABBOTT Advisor One-Step Pregnancy Test is an over-the counter in vitro test which can be used by the consumer to detect pregnancy as early as the first day of her missed period, using a direct urine stream sampling method. Some positive results appear as soon as three minutes, however, all results are confirmed when the Test Timer turns pink/red. The Test Timer will turn pink/red approximately 5 minutes after the urine has been added to the test device.
Device Description
The ABBOTT Advisor One-Step Pregnancy Test is an elongated device composed of two pieces of molded plastic which contain the internal test strip. The three openings on the device are the Urine Well, the Result Window and the Test Timer. The Result Window and the Test Timer are protected with a clear seal to prevent potential contamination caused by splashing urine.