← Product Code [HGK](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGK) · K954982 # KSEA SCALP BLOOD COLLECTION SET (K954982) _KARL STORZ Endoscopy-America, Inc. · HGK · Jul 17, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGK/K954982 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [HGK](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGK.md) - **Decision Date:** Jul 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1660 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## 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). ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 0 Ka 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 000027 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGK/K954982](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGK/K954982) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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