(99 days)
Not Found
No
The description focuses on the mechanical and optical components of a standard hysteroscopy system and does not mention any AI/ML capabilities or image processing beyond basic visualization.
Yes
The device aids in performing diagnostic and surgical procedures by providing visualization and enabling the introduction of surgical instruments, thus having a direct therapeutic role.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is "used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures."
No
The device description explicitly lists hardware components such as an obturator, sheath, and hysteroscope, indicating it is a physical medical device system, not software-only.
Based on the provided information, the Interlace Medical Operative Hysteroscopy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Interlace Medical Operative Hysteroscopy System is used for direct visualization of the cervical canal and uterine cavity within the body (in vivo) and for performing surgical procedures. It is a tool for direct observation and intervention, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states "viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." This describes an in-vivo procedure.
- Device Description: The description details the components (obturator, sheath, hysteroscope) and how they are used to visualize and operate within the uterus. This aligns with an in-vivo surgical/diagnostic tool.
Therefore, the Interlace Medical Operative Hysteroscopy System falls under the category of a surgical or diagnostic instrument used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic ond surgical procedures.
Product codes
HIH
Device Description
The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures. The Operative Hysteroscopy System includes an obturator, a sheath and a hysteroscope. The obturator is used to facilitate introduction of the sheath into the uterine cavity. The single use sheath includes a working channel to permit the introduction of instrumentation. The reusable fiber optic hysteroscope is designed with optical lenses for visualization and optical fibers for illumination. The obturator is inserted into the working channel of the sheath and the hysteroscope is inserted into a designated lumen of the sheath. The Operative Hysteroscopy System can be combined with a hysteroscopic fluid management system (not the subject of this submission) to provide continuous flow hysteroscopy capability. The hysteroscope can be used with standard O.R. camera couplers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and the uterine cavity
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Interlace Medical Operative Hysteroscopy System meets electrical safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Interlace Medical Incorporated Operative Hysteroscopy System
Premarket Notification
Interlace Medical, Inc. Operative Hysteroscopy System 510K Summary of Safety and Effectiveness April 11, 2008
JUL 23 2008
- 1 . Sponsor Name Interlace Medical Inc. 139 Newbury St Framingham, MA 01701 Telephone: 508.875.1343
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- Device Name Proprietary Name: Interlace Medical Operative Hysteroscopy System Common/Usual Name: Hysteroscope and accessories
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- Identification of Predicate or Legally Marketed Device The Interlace Medical Operative Hysteroscopy System is substantially equivalent to the Smith and Nephew Hysteroscope and Accessories cleared under K013870
4. Device Description
The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures. The Operative Hysteroscopy System includes an obturator, a sheath and a hysteroscope. The obturator is used to facilitate introduction of the sheath into the uterine cavity. The single use sheath includes a working channel to permit the introduction of instrumentation. The reusable fiber optic hysteroscope is designed with optical lenses for visualization and optical fibers for illumination. The obturator is inserted into the working channel of the sheath and the hysteroscope is inserted into a designated lumen of the sheath. The Operative Hysteroscopy System can be combined with a hysteroscopic fluid management system (not the subject of this submission) to provide continuous flow hysteroscopy capability. The hysteroscope can be used with standard O.R. camera couplers.
-
- Intended Use Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
-
- Comparison of Technological Characteristics The Interlace Medical Operative Hysteroscopy System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same. Since the Interlace Medical Operative Hysteroscopy System has the same intended use and
1
Interlace Medical Incorporated Operative Hysteroscopy System
technological characteristics as the predicate device, the Interlace Medical Operative Hysteroscopy System does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.
The descriptive characteristics demonstrate that the Interlace Medical Operative Hysteroscopy System are substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
- 7 Performance Testing The Interlace Medical Operative Hysteroscopy System meets electrical safety standards.
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- Statement of Equivalency
The Interlace Medical Operative Hysteroscopy System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same. Since the Interlace Operative Hysteroscopy System has the same in intended use and technological characteristics as the predicate device, the Interlace Operative Hysteroscopy System does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.
The descriptive characteristics demonstrate that the Interlace Operative Hysteroscopy System is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IJUL 2 3 2008
Mr. Ron Adams Chief Technical Officer Interlace Medical 139 Newbury Street FRAMINGHAM MA 01701
Re: K081070
Trade Name: Interlace Medical Operative Hysteroscopy System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: June 13, 2008 Received: June 17, 2008
Dear Mr. Adams:
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 Fodcral 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 (PMA), 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.
3
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 Actor 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification
Indications for Use
510(k) Number (if known): TBD KORION
Device Name: Interlace Medical Operative Hysteroscopy System
Indications For Use:
Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic ond surgical procedures.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Huld Semen
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
000011