(29 days)
Not Found
No
The description focuses on mechanical and software control of a motor and cutter, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for hysteroscopic intrauterine procedures to resect and remove tissue, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
The device is described as a "Tissue Removal System" intended for "resect and remove tissue," indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines multiple hardware components including a control unit, tissue removal device (morcellator with cutter blade), and foot pedal. While the control unit contains software, the device is fundamentally a hardware system with software control.
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 taken from the human body (like blood, urine, tissue samples) to provide information about a person's health, diagnose conditions, or monitor treatment. This testing is done outside of the body (in vitro).
- Device Function: The MyoSure Hysteroscopic Tissue Removal System is used inside the body (in vivo) during a surgical procedure to physically remove tissue. It is a surgical tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it's for "hysteroscopic intrauterine procedures... to resect and remove tissue." This describes a surgical intervention, not a diagnostic test.
- Device Description: The description details a mechanical system for cutting and aspirating tissue, consistent with a surgical device.
Therefore, the MyoSure Hysteroscopic Tissue Removal System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MyoSure™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
Product codes
HIH
Device Description
The modified MyoSure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate MyoSure System: - MyoSure Control Unit O - MyoSure Tissue Removal Device o - MyoSure Foot Pedal o The MyoSure Control Unit contains an electric motor and software controller that drives the MyoSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSure Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSure Tissue Removal Device features a rotating/reciprocating (2.5 mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter-blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the MyoSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained gynecologist
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 modified MyoSure Hysteroscopic Tissue Removal System meets electrical safety and EMC standards. New patient contact materials in the modified MyoSure device meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. In addition, in-vitro testing demonstrated that the modified MyoSure device's performance is equivalent to the predicate MyoSure device.
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 Inc.
510(k) SUMMARY 5.
Submitter: 1.
Interlace Medical Inc. 135 Newbury St Framingham, MA 01701 Telephone: 508.875.1343, ext. 112 MAR 3 0 2010
Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: February 26, 2010
2. Device:
Trade Name: MyoSure™ Hysteroscopic Tissue Removal System Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II
Predicate Device: 3.
MyoSure™ Hysteroscopic Tissue Removal System (K091100)
Device Description: 4.
The modified MyoSure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate MyoSure System:
- MyoSure Control Unit O
- MyoSure Tissue Removal Device o
- MyoSure Foot Pedal o
The MyoSure Control Unit contains an electric motor and software controller that drives the MyoSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSure Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSure Tissue Removal Device features a rotating/reciprocating (2.5 mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter-blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the MyoSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.
1
5. Intended Use:
The MyoSure™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
Comparison of Characteristics: 6.
The modified MyoSure Hysteroscopic Tissue Removal System's intended use and indicated use are identical to that of the predicate MyoSure Hysteroscopic Tissue Removal System, K091100.
The principles of operation and primary functional specifications of the modified MyoSure Hysteroscopic Tissue Removal System are identical to those of the predicate MyoSure Hysteroscopic Tissue Removal System.
The primary functional components of the modified MyoSure Hysteroscopic Tissue Removal System are identical to those of the predicate MyoSure Hysteroscopic Tissue Removal System, i.e.:
- each system employs a sterile, single use, Tissue Removal Device . (disposable straight surgical morcellator),
- a Foot Pedal controls activation and deactivation of a motor in the . Control Unit which powers the morcellator in both systems,
- the modified MyoSure cutter rotates and reciprocates at a fixed rate ● that is identical to the predicate device, and
- the modified MyoSure cutter blade tip design is identical to that of the . predicate device, and
The modified MyoSure Hysteroscopic Tissue Removal System is different · from the predicate MyoSure Hysteroscopic Tissue Removal System as follows:
- The modified MyoSure Control Unit's motor control software has been o changed to firmware and the controller component has been modified accordingly.
- The maximum running current limit and current limit has been decreased o in the modified MyoSure device.
- The modified MyoSure Tissue Removal Device morcellator's cutting tube O outer surface is now coated with a different material than was used in the predicate device.
- An O ring in the predicate device's fluid path has been changed to a o different material in the modified MyoSure™ Hysteroscopic Tissue Removal System.
2
- The modified MyoSure™ Hysteroscopic Tissue Removal System utilizes o a lubricant on the device's gear mechanism and O ring while the predicate MyoSure device had no gear lubrication.
Performance Testing: 7.
The modified MyoSure Hysteroscopic Tissue Removal System meets electrical safety and EMC standards. New patient contact materials in the modified MyoSure device meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. In addition, in-vitro testing demonstrated that the modified MyoSure device's performance is equivalent to the predicate MyoSure device.
8. Conclusion:
Based on the intended use, descriptive information and performance evaluation provided in this submission, the modified MyoSure Hysteroscopic Tissue Removal System has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicate MyoSure Hysteroscopic Tissue Removal System.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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
MAR 3 0 2010
Re: K100559
Trade Name: MyoSure Hysteroscopic Tissue Removal System Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: February 26, 2010 Received: March 1, 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
4
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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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Interlace Medical Inc.
4. INDICATIONS FOR USE STATEMENT
KI00559 510(k) Number (if known):
Device Name: MyoSURE™ Hysteroscopic Tissue Removal System
Indications For Use:
The MyoSURE™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
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)
(Division Stan-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
CONFIDENTIAL