(98 days)
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Not Found
No
The provided text describes a hysteroscopic introducer and a steerable working channel, which are mechanical devices used for access and visualization during hysteroscopic procedures. There is no mention of any software, algorithms, image processing, or AI/ML terms.
No
The devices are used to provide access for hysteroscopic instruments, which can be diagnostic or therapeutic, but the device itself does not perform therapy.
Yes
The device is used to facilitate both diagnostic and operative hysteroscopic procedures, directly mentioning its use in "Diagnostic Hysteroscopy" for various conditions.
No
The device description and intended use clearly describe physical instruments (Hysteroscopic Introducer, Steerable Working Channel) used for surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the Optivia Hysteroscopic Introducer and Steerable Working Channel are used within the uterus to facilitate hysteroscopic procedures. They are tools for accessing and manipulating the uterine cavity, not for analyzing specimens taken from the body.
- Intended Use: The intended uses listed are diagnostic and operative hysteroscopic procedures, which involve direct visualization and intervention within the uterus.
Therefore, the function and intended use of this device fall under the category of a surgical or procedural device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optivia Hysteroscopic Introducer is used to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as:
Diagnostic Hysteroscopy
Infertility and Pregnancy Wastage
Abnormal Uterine Bleeding
Evaluation of Abnormal Hysterosalpingogram
Intrauterine Foreign Body
Amenorrhea
Pelvic Pain
Operative Hysteroscopy
Removal opf Submucous Fibroids and Large Polyps
Direct Biopsy
Transection of Intrauterine Adhesions
Submucous Myomectomy
Transection of Intrauterine Septa
Endometrial Ablation
The Optivia Steerable Working Channel is used only in conjunction with the Optivia Hysteroscopic Introducer to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as:
Diagnostic Hysteroscopy
Infertility and Pregnancy Wastage
Abnormal Uterine Bleeding
Evaluation of Abnormal Hysterosalpingogram
Intrauterine Foreign Body
Amenorrhea
Pelvic Pain
Operative Hysteroscopy
Removal opf Submucous Fibroids and Large Polyps
Direct Biopsy
Transection of Intrauterine Adhesions
Submucous Myomectomy
Transection of Intrauterine Septa
Endometrial Ablation
The Optivia Steerable Working Channel aids in visualization and gives the health care professional the ability to more precisely control the position of the diagnostic or therapeutic device than is achievable without the Steerable Working Channel.
Product codes (comma separated list FDA assigned to the subject device)
HIH
Device Description
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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
Uterus, uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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.
Not Found
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).
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes. The bird is facing to the right and has a curved body and tail.
Public Health Service
MAR 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert M. Kelly Official Correspondent OptiVia Medical, LLC 101 N. Chestnut Street, Suite 305 WINSTON-SALEM NC 27101
Re: K053583
Trade/Device Name: Optivia Hysteroscopic Introducer and Optivia Steerable Working Channel Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: February 27, 2006 Received: February 28, 2006
Dear Mr. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and h yours of substantial equivalence of your device to a legally prematice notification: - The sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dearle sportie at not of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Andy prouse the regarities general information on your responsibilities under the Act from the 60 : 7 / 9 : 1 : 0 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
T. Nancy C. Brigdon
Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): _K053 583
Device Name: __ Optivia OM100 Hysteroscopic Introducer
Indications for Use:
The Optivia Hysteroscopic Introducer is used to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as:
| Diagnostic Hysteroscopy | Operative Hysteroscopy |
|---|---|
| Infertility and Pregnancy Wastage | Removal opf Submucous Fibroids and |
| Large Polyps | |
| Abnormal Uterine Bleeding | |
| Evaluation of Abnormal | |
| Hysterosalpingogram | Direct Biopsy |
| Transection of Intrauterine Adhesions | |
| Intrauterine Foreign Body | Submucous Myomectomy |
| Amenorrhea | |
| Pelvic Pain | Transection of Intrauterine Septa |
| Endometrial Ablation |
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nanci C Broadon
Division Sign-Off Division of Reproductive, Abdomin and Radiological Device 510(k) Number
3
Indications for Use
510(k) Number (if known): _K053583
Device Name: Optivia OM 200 Steerable Working Channel
Indications for Use:
The Optivia Steerable Working Channel is used only in conjunction with the Optivia Hysteroscopic Introducer to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as:
| Diagnostic Hysteroscopy | Operative Hysteroscopy |
|---|---|
| Infertility and Pregnancy Wastage | Removal opf Submucous Fibroids and |
| Large Polyps | |
| Abnormal Uterine Bleeding | Direct Biopsy |
| Evaluation of Abnormal | |
| Hysterosalpingogram | Transection of Intrauterine Adhesions |
| Intrauterine Foreign Body | Submucous Myomectomy |
| Amenorrhea | Transection of Intrauterine Septa |
| Pelvic Pain | Endometrial Ablation |
The Optivia Steerable Working Channel aids in visualization and gives the health care professional the ability to more precisely control the position of the diagnostic or therapeutic device than is achievable without the Steerable Working Channel.
AND/OR
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thand C. Sypm
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Dev 510(k) Number
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