(260 days)
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No
The device description and intended use clearly describe a manually operated surgical instrument for blood collection, with no mention of AI or ML capabilities.
No
The device is used to collect blood, which is a diagnostic procedure, not a therapeutic one.
No
The device is described as a blood collection set used to "draw blood." This indicates a tool for obtaining a sample, not for analyzing or interpreting information to determine the presence or absence of a disease or condition. Its purpose is procedural, not diagnostic.
No
The device description explicitly states it is a "manually operated, reusable surgical device consisting of handle, blade holder and tubing," which are physical hardware components.
Based on the provided information, the KSEA Scalp Blood Collection Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to draw blood from the fetal scalp. This is a procedure to obtain a sample, not to perform a diagnostic test on the sample itself.
- Device Description: The description details a surgical device for collecting a sample, not a device that analyzes biological samples in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or interpretation of the collected blood sample. IVDs are designed to provide information about a physiological state, disease, or condition through the examination of biological samples.
The KSEA Scalp Blood Collection Set is a surgical device used for sample collection. The diagnostic testing would occur after the blood is collected, using separate IVD devices or laboratory procedures.
N/A
Intended Use / Indications for Use
The KSEA Scalp Blood Collection Set is intended to to draw blood from the fetal scalp during obstetric endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The KSEA Scalp Blood Collection Set is a manually operated, reusable surgical device consisting of handle, blade holder and tubing. The instrument is long enough to gain access to the surgical area and is designed to be used as an accessory to an endoscope. The body contact materials are surgical grade stainless steel and medical grade PVC.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fetal scalp
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 884.1660 Transcervical endoscope (amnioscope) and accessories.
(a)
Identification. A transcervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of an open tube introduced into the uterus through the cervix. The device may be used to visualize the fetus or amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, light sources and cables, and component parts.(b)
Classification. Class II (performance standards).
0
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600 Cornorate Pointe Culver City, California 40230-7 Phone 310 558 1500
Toll Frie 80. 12 Fax 31 ] 4 ' (
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUL 17 1988
I his summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Contact:
Betty M. Johnson Manager, Regulatory Affairs
Device Identification:
Common Name Fetal Blood Sampler
Trade Name Karl Storz Scalp Blood Collection Set
Indication: The KSEA Scalp Blood Collection Set is intended to to draw blood from the fetal scalp during obstetric endoscopic procedures.
Device Description: The KSEA Scalp Blood Collection Set is a manually operated, reusable surgical device consisting of handle, blade holder and tubing. The instrument is long enough to gain access to the surgical area and is designed to be used as an accessory to an endoscope. The body contact materials are surgical grade stainless steel and medical grade PVC.
Substantial Equivalence: The KSEA Scalp Blood Collection Set is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA Scalp Blood Collection Set and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Beth M. Johnson
Betty M. Johnson Manager, Regulatory Affairs