K954982 · KARL STORZ Endoscopy-America, Inc. · HGK · Jul 17, 1996 · Obstetrics/Gynecology
Device Facts
Record ID
K954982
Device Name
KSEA SCALP BLOOD COLLECTION SET
Applicant
KARL STORZ Endoscopy-America, Inc.
Product Code
HGK · Obstetrics/Gynecology
Decision Date
Jul 17, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.1660
Device Class
Class 2
Indications for Use
The KSEA Scalp Blood Collection Set is intended to draw blood from the fetal scalp during obstetric endoscopic procedures.
Device Story
Manually operated, reusable surgical device; used as accessory to endoscope; facilitates fetal scalp blood collection during obstetric procedures. Components: handle, blade holder, tubing. Operation: clinician inserts device through endoscope to access fetal scalp; collects blood sample for diagnostic analysis. Benefits: enables minimally invasive fetal blood sampling; assists in clinical assessment of fetal status.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Materials: surgical grade stainless steel, medical grade PVC. Design: manual, reusable, long-reach instrument for endoscopic accessory use. No energy source. Sterilization: reusable (implies standard autoclave/chemical sterilization).
Indications for Use
Indicated for fetal scalp blood sampling during obstetric endoscopic procedures.
Regulatory Classification
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.
Submission Summary (Full Text)
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600 Corporate Pointe
Culver City, California 90230-7600
Phone 310 558 1500
Toll Free 80-42-3807
Fax 310 444-527
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUL 17 1996
This 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
K 954982
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 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:
Betty M. Johnson
Manager, Regulatory Affairs
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