(28 days)
Not Found
No
The document describes a mechanical accessory (seals) for a hysteroscope and does not mention any computational or analytical functions, let alone AI/ML.
No
The device is described as a component/accessory that prevents fluid leakage and provides an insertion pathway for instruments, not directly treating a condition.
No
Explanation: The device is described as a component/accessory to a hysteroscope used to prevent fluid leakage and provide an insertion pathway for instruments. It does not perform any diagnostic function itself.
No
The device description explicitly states it is comprised of "white-tinted silicone," indicating it is a physical component and not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent fluid leakage during a hysteroscopy procedure, which is a surgical/endoscopic procedure performed on the patient's body.
- Device Description: The device is a seal for a hysteroscope, which is an instrument used to visualize the inside of the uterus.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information.
- No mention of diagnostic purpose: The purpose is functional (preventing leakage) during a procedure, not to diagnose a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
MyoSure™ Single Use Seals are a component / accessory to the MyoSure™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.
Product codes
HIH
Device Description
The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.
MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The modified MyoSure™ Single Use Seals meet the biocompatibility requirements of ISO 10093-1 Biological Evaluation of Medical Devices as well as bench test performance requirements established by Interlace Medical, Inc.
Key Metrics
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 Inc.
K102686
pg. 1 of 2
510(k) SUMMARY 5.
-
- Submitter:
Interlace Medical Inc. 135 Newbury St Framingham, MA 01701 Telephone: 508.875.1343, ext. 112
- Submitter:
Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: September 14, 2010
2. Device:
Trade Name: MyoSure™ Single Use Seals Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II
3. Predicate Device:
MyoSure™ Rod Lens Hysteroscope and Accessories (K091465)
4. Device Description:
The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.
MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.
5. Intended Use:
MyoSure™ Single Use Seals are a component / accessory to the MyoSure™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.
OCT 1 5 2010
1
Premarket Notification
K102686
PG: 2 of 2
Comparison of Characteristics: 6.
The design, principles of operation, primary functional specifications and materials of composition of the modified MyoSure™ Single Use Seals are equivalent to those of the predicate scope seals described in the MyoSure™ Rod Lens Hysteroscope (K091465) submission in that:
- all seals are fabricated from silicone, ●
- all seals are dimensionally identical, .
- all seals are required to be sterile prior to being placed in the . MyoSure™ Rod Lens Hysteroscope and outflow channel,
The modified MyoSure™ Single Use Seals' intended use is identical to that of the predicate scope seals (K091465).
7. Performance Testing:
The modified MyoSure™ Single Use Seals meet the biocompatibility requirements .
of ISO 10002, 1 Rialacio d Engle Children of Seat of ISO 10993-1 Biological Evaluation of Medical Devices as well as bench test performance requirements established by Interlace Medical, Inc.
8. Conclusion:
Based on the intended use, descriptive information and performance evaluation provided in this submission, the modified MyoSure™ Single Use Seals have been shown to be equivalent in technology, method of operation, functional performance and intended use to the previously referenced predicate seals.
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2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002.
Mr. John Vozella V.P. Clinical and Regulatory Affairs Interlace Medical, Inc. 135 Newbury Street FRAMINGHAM MA 01701
i 5 c.v.h
Re: K102686
Trade Name: MyoSURETM Single Use Seals Regulation Number: 21 CFR $884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: September 14, 2010 Received: September 17, 2010
Dear Mr. Vozella:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
3
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Interlace Medical Inc.
Premarket Notification
4. INDICATIONS FOR USE STATEMENT
OCT 1 5 2010
510(k) Number (if known): KID2696
Device Name: MyoSure™ Single Use Seals
Indications For Use:
MyoSure™ Single Use Seals are a component / accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
510(k) Number .
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)
| (Division Sign-Off) |
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| Division of Reproductive, Gastro-Renal, and Urological Devices |
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