(260 days)
The KSEA Scalp Blood Collection Set is intended to to draw blood from the fetal scalp during obstetric endoscopic procedures.
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.
The provided document is a 510(k) summary for a "KSEA Scalp Blood Collection Set" from July 17, 1998. It describes a medical device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence based on design, materials, and intended use being similar to existing devices, implying that if the predicate devices were safe and effective, then this new device is also considered safe and effective for its indicated use.
Therefore, for your request, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present, as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth or expert review for a test set is mentioned.
- Adjudication method for the test set: Not applicable.
- 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 medical device (surgical instrument), not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical instrument, not an algorithm.
- The type of ground truth used: Not applicable, as no performance study generating ground truth is described.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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
§ 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).