(455 days)
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Not Found
No
The device description and performance studies focus on electrical stimulation and monitoring, with no mention of AI or ML.
Yes
The device is intended to induce seminal emission in patients for whom prior or present illness precludes their ability to spontaneously ejaculate, which addresses a health condition.
No
The device is an electroejaculator intended to induce seminal emission, which is a therapeutic function, not a diagnostic one. It stimulates ejaculation, rather than identifying or analyzing a condition.
No
The device description explicitly states it consists of a "power unit and rectal probe" which are hardware components designed to deliver electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Seager Model Electroejaculator is a device that induces a physiological process (ejaculation) within the body. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to induce seminal emission in patients who cannot spontaneously ejaculate. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details the electrical stimulation of internal organs (prostate gland and seminal vesicles) via a rectal probe. This is an in vivo (within the living body) procedure.
- Performance Studies: The performance studies evaluate the device's ability to induce ejaculation and its safety during the procedure, not the analysis of a biological sample.
While the device helps obtain a biological sample (ejaculate), the device itself is not performing an in vitro diagnostic test on that sample. The analysis of the ejaculate (e.g., for sperm viability) would be a separate process, potentially using IVD devices, but the electroejaculator is not that device.
N/A
Intended Use / Indications for Use
The Seager Model Electroejaculator (EE) is intended to induce seminal emission in patients for whom prior or present illness precludes their . ability to spontaneously ejaculate. The EE device is indicated for use in neurologically impaired males who are 18 yrs. and anejaculatory due to the following conditions:
Spinal Cord Injury (paralysis)
Retroperitoneal Lymph Node Dissection (RPLND) fsurgical therapy post testicular cancer]
Idiopathic (neuropsychosis/psychogenic)
Diabetes
Spina Bifida
Pelvic Surgery Complications
Multiple Sclerosis (MS)
Neurological Impairments
The EE device is contraindicated in the following individuals:
Chron's Disease
Ulcerative Colitis
Rectal cancer or other significant rectal pathology
Patients with pacemakers or other artificial heart device
Product codes (comma separated list FDA assigned to the subject device)
78 LNL
Device Description
The Seager EE device consists of a power unit and rectal probe which is designed to provide low level (5-10 volts) electrical stimulation. The rectal probes vary in diameter from 1 inch to 1 5/16 inches. Prior to the procedure, a rectal exam is performed to determine the correct probe size and assure that the rectal mucosa are not compromised. For spinal cord injured patients with lesions at T-6 or above, or patients at risk of dysreflexia (elevated blood pressure), this may be controlled with appropriate medication (e.g. Procardia; nitrogylcerine). For non spinal cord injured patients whose lesion may be Incomplete, short general anesthesia (GA) may be administered.
The rectal probe is inserted into the rectum and a series of low level electrical stimulations are delivered to the prostate gland and seminal vesicles. Once the patient begins to ejaculate (usually after 5 to 10 stimulations), additional stimulations (10 to 12) are applied to obtain the entire ejaculate volume. During the procedure, patient comfort and blood pressure are monitored. If blood pressure increases above 180 systolic and/or 120 diastolic, the procedure is halted until pressures return to normal and the patient wishes to continue. After discontinuation of rectal stimulation, blood pressure is monitored until it returns to normal physiological levels. Following the procedure, the rectal mucosa is re-examined to assess any changes from pre-stimulation.
The approximate weight and the shape of the probes are the same. The diameters: A. Stiebel's is 1 inch; Seager's is 1 1/4 inch. The intended use and the placement of the probes is the same. Sterilization methods are also the same.
The rectal probe, which comes into short-term (3-5 minutes) contact with the rectal mucosa, is manufactured from medical grade (306) stainless steel electrodes embedded in a polyvinylchloride (grade 6 PVC) substrate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectum, prostate gland, seminal vesicles
Indicated Patient Age Range
18 yrs.
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multi-center clinical investigation to evaluate the safety and effectiveness of the EE device was conducted at 13 sites in the US. A total of 403 subjects participated in a single arm non randomized study to determine if ejaculation could be induced in patients who previously were not able to produce ejaculate normally. The study group averaged 32.6 years of age (range 19 to 60). Patients average age at injury was 23 years (range 0 to 54). Of the 403 patients, 346 (85.9%) were spinal cord injured and 57 (14.1%) were non spinal cord injured.
Safety: Assessed by examining changes in blood pressure compared to normal physiological range during the procedure and any post-procedure changes in rectal mucosa from pre-stimulation baseline. Systolic/diastolic pressures recorded before, during and at the end of the EE procedure were compared to normal physiological at rest (120/80), normal physiological during exercise (160/100) and normal physiological at rest (120/80) respectively. Other than slightly elevated systolic blood pressures after termination of the EE procedure (3 - 7 mm Hq, p
N/A
0
Appendix 6
Seager Electroejaculator Summary of Safety and Effectiveness
SEP 1 8 1997
K962379
146
7.0 Summary of Safety and Effectiveness
Indications for Use
The Seager Model Electroejaculator (EE) is intended to induce seminal emission in patients for whom prior or present illness precludes their . ability to spontaneously ejaculate. The EE device is indicated for use in neurologically impaired males who are 18 yrs. and anejaculatory due to the following conditions:
Spinal Cord Injury (paralysis)
Retroperitoneal Lymph Node Dissection (RPLND) fsurgical therapy post testicular cancer]
Idiopathic (neuropsychosis/psychogenic)
Diabetes
ﻟﺴﻴﺴﺎ
Spina Bifida
Pelvic Surgery Complications
Multiple Sclerosis (MS)
Neurological Impairments
The EE device is contraindicated in the following individuals:
Chron's Disease
Ulcerative Colitis
Rectal cancer or other significant rectal pathology
Patients with pacemakers or other artificial heart device
Alternative Treatments
Other available methods of inducing ejaculation in neurologically impaired individuals include vibration, (success limited to those with high sci lesions) or invasive procedures such as vas aspiration, epididymal aspiration and testicular aspiration or biopsy.
Historical Development of Electroejaculation
The first study of electroejaculation in neurologically impaired males (Horne et al, 1948') reported successful ejaculation in 11 of 18 (61%) participants. The authors used low level electrical current (45-60
1
Seager Electroejaculator Summary of Safety and Effectiveness
K 16 2 37 9
246
milliamperes) to stimulate the prostate and seminal vesicles. Between 1948 and 1962, three additional reports described efforts to electrically stimulate the prostate in both intact and spinal cord ersentially Collector on Economist & Holliger, 1950'; Potts, 1957;
injured males (Bors, Engle, Rosenquist & Holliger, 1950'; engles successful production of ejaculation.
i
Subsequent studies in both animals (Francois, Maury, Vacant, Clukier & David, 1975-) and humans (David, Ohry & Rosen, 1977-786; Francois, David, 1973 ) and namand (barra) only a provided further experience with electroejaculation that led to a series of landmark articles by Brindley (1980-19848-19) describing his experience with EE in over 100 spinal cord injured men. His work represented the first in depth examination of 1) electrode positioning to achieve more precise stimulation of anatomic structures;
- previous animal experience in EE with non human primates; 3) various aspects of technique, equipment and safety issues involved in EE; 4) the correlation of anatomic and physiological factors with successful stimulations; and 5) the first attempt to correlate level of injury and successful ejaculation (none was noted).
A study by Martin et al (1983) examined the safety parameters of repeated electrical stimulation to the rectal mucosa. The authors examined the effect of low level electrostimulation (ES) in both intact (N=8) and SCI males (N=12). The pain resulting from ES precluded erection or ejaculation in intact men. However, minimal discomfort was experienced by spinal cord injured subjects. Rectal scopic exams post stimulation showed mild erythema due to the heating of the rectal The number of patients demonstrating this finding, the length mucosa. of stimulation, stimulation parameters, or any attempt to directly measure local mucosal temperature was not mentioned.
The first attempt to evaluate the effect of chronic electrostimulation (ES) in an SCI animal model was reported by Seager et al. in 1984''s Rectal stimulation was applied in a group of 12 monkeys with transected spinal cords (and a control with intact spine) on a monthly basis for over two years. Ejaculation was achieved in all animals. Autopsy studies revealed no abnormalities associated with chronic ES and tissue samples from the rectum, seminal vesicles, prostate, testes and epididymis were normal.
Based on this experience in SCI monkeys, as well as 20 years of prior research with over 100 species of animals (Seager, Wildt & Platz, 198012, Seager, 1983'3) the electroejaculation technique was refined to the procedure used in the study reported herein.
Device Description and Principle of Operation
The Seager EE device consists of a power unit and rectal probe which is designed to provide low level (5-10 volts) electrical stimulation. The rectal probes vary in diameter from 1 inch to 1 5/16 inches. Prior to
2
Seager Electroejaculator Summary of Safety and Effectiveness
3:16
the procedure, a rectal exam is performed to determine the correct probe size and assure that the rectal mucosa are not compromised. For spinal cord injured patients with lesions at T-6 or above, or patients at risk of dysreflexia (elevated blood pressure), this may be controlled with appropriate medication (e.g. Procardia; nitrogylcerine). For non spinal cord injured patients whose lesion may be Incomplete, short general anesthesia (GA) may be administered.
The rectal probe is inserted into the rectum and a series of low level electrical stimulations are delivered to the prostate gland and seminal Once the patient begins to ejaculate (usually after 5 to 10 vesicles. stimulations), additional stimulations (10 to 12) are applied to obtain the entire ejaculate volume. During the procedure, patient comfort and blood pressure are monitored. If blood pressure increases above 180
systolic and/or 120 diastolic, the procedure is halted until pressures return to normal and the patient wishes to continue. After discontinuation of rectal stimulation, blood pressure is monitored until it returns to normal physiological levels. Following the procedure, the rectal mucosa is re-examined to assess any changes from pre-stimulation.
Support for Substantial Equivalents of Seager Electroejaculation Equipment as compared to similar equipment developed by Mr. A. Stiebel.
Mr. Stiebel's electroejaculation eguipment was patented October 1, 1958, U.S. Patent Number 3403684. The device was an electric probe placed in the rectum for bringing about ejaculation in spinal cord injured and other neurologically impaired men. Seager was also granted a U.S. Patent Number 07 701815, filed May 20, 1991, that used a similar technology of placing a probe in the rectum and then by electrical impulse bringing about ejaculation in the same patient population.
The approximate weight and the shape of the probes are the same. The diameters: A. Stiebel's is 1 inch; Seager's is 1 1/4 inch. The intended use and the placement of the probes is the same. Sterilization methods are also the same.
Mr. Stiebel built his equipment with the help of persons who were involved with spinal cord injury as did Dr. Seager. He has certified that he made significant attempts to market this device both inter and intra-state and also in foreign countries.
The intention of this 510k application is to demonstrate substantial equivalents to this very similar device.
Material Biocompatibility Studies
The rectal probe, which comes into short-term (3-5 minutes) contact with the rectal mucosa, is manufactured from medical grade (306) stainless steel electrodes embedded in a polyvinylchloride (grade 6 PVC) substrate. Material biocompatibility was evaluated by cytotoxicity (USP elution) and USP intracutaneous toxicity (extracts).
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Seager Electroejaculator Summary of Safety and Effectiveness
446
Testing results indicated that the rectal probe materials were non-cytotoxic and showed no evidence of significant irritation or toxicity when injected intracutaneously into rabbits. Based on the results of these studies, the compatibility of probe materials for short-term rectal mucosal contact were supported.
Results of Clinical Studies
A multi-center clinical investigation to evaluate the safety and effectiveness of the EE device was conducted at 13 sites in the US. A total of 403 subjects participated in a single arm non randomized study to determine if ejaculation could be induced in patients who previously were not able to produce ejaculate normally. The study group averaged 32.6 years of age (range 19 to 60). Patients average age at injury was 23 years (range 0 to 54). Of the 403 patients, 346 (85.9%) were spinal cord injured and 57 (14.1%) were non spinal cord injured.
The effectiveness of the EE device for its intended use was assessed by the production of ejaculate in an otherwise anejaculatory male. In order to confirm the safety of the device, successful ejaculation would be accomplished with minimal risk of dysreflexia (elevated blood pressure) and other untoward events including rectal mucosal burning or perforation.
The safety of the EE device was assessed by examining changes in blood pressure compared to normal physiological range during the procedure and any post-procedure changes in rectal mucosa from pre-stimulation baseline. Systolic/diastolic pressures recorded before, during and at the end of the EE procedure were compared to normal physiological at rest (120/80), normal physiological during exercise (160/100) and normal physiological at rest (120/80) respectively. Other than slightly elevated systolic blood pressures after termination of the EE procedure (3 - 7 mm Hq, p