(111 days)
The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
The system consists of the following components: Control Unit, Morcellator Handpiece, Single Use Morcellator, Footswitch. The Interlace Medical Hysteroscopic Morcellation System will be used with standard hysteroscopes and fluid management systems.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Electrical safety and EMC standards met | Device meets electrical safety and EMC standards. |
| In-vitro performance equivalent to or better than predicate device | An in-vitro test "demonstrated that the device performs equivalent to or better than the predicate device." |
| Substantial equivalence in design, materials, construction, and intended use as predicate | Device is "substantially equivalent in design, materials, construction and intended use as that of the predicate." |
| No new safety and efficacy concerns compared to predicate | Device "does not raise any new safety and efficacy concerns when compared to the similar legally marketed device." |
| Capable of safely and accurately performing intended use | Device is "capable of safely and accurately performing the stated intended use." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "an in-vitro test" but does not specify the sample size (e.g., number of morcellations, amount of tissue removed, or number of devices tested).
- Data Provenance: The study was "in-vitro," meaning it was conducted in a lab setting, not on human subjects. The country of origin of the data is not explicitly stated, but given the sponsor is Interlace Medical Inc. located in Framingham, MA, USA, and the FDA review, it is highly probable the testing was conducted in the USA. It was a prospective test, as it was conducted to demonstrate device performance for regulatory approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. As the study was an in-vitro performance test comparing the device to a predicate, it likely involved objective measurements based on engineering or laboratory protocols rather than human expert interpretation of results.
4. Adjudication method for the test set:
This information is not provided. Given the nature of the in-vitro performance test, it's unlikely a human adjudication method (like 2+1, 3+1) was used. Performance would have been measured against technical specifications or direct comparison to the predicate device's measured performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. A MRMC comparative effectiveness study was not done. The device is a medical instrument (Hysteroscopic Morcellation System), not an AI-powered diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The "in-vitro test" mentioned in point 7 of the "Performance Testing" section can be considered a standalone performance evaluation of the device's mechanical function, without direct human-in-the-loop performance measurement for regulatory submission purposes. The device's operation is mechanical, and its performance was assessed in a controlled environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the in-vitro performance test would have been established by objective technical measurements and engineering specifications related to the device's ability to resect and remove tissue, compared directly against the performance of the predicate device under similar conditions. This is not comparable to ground truth derived from expert consensus, pathology, or outcomes data, which are typically used for diagnostic or screening devices.
8. The sample size for the training set:
Not applicable/Not provided. The Interlace Medical Hysteroscopic Morcellation System is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established:
Not applicable. As stated above, there is no training set for this device.
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Interlace Medical Inc. Hysteroscopic Morcellation System Premarket Notification
Interlace Medical Hysteroscopic Morcellation System 510K Summary of Safety and Effectiveness April 11, 2008
APR 1 7 2008
- Sponsor Name Sponsor/Manufacturer Interlace Medical Inc. 139 Newbury St Framingham, MA 01701 Telephone: 508.875.1343
-
- Device Name Proprietary Name: Interlace Medical Hysteroscopic Morcellation System Common/Usual Name: Hysteroscope and accessories
- Identification of Predicate or Legally Marketed Device 3. The Interlace Medical Hysteroscopic Morcellation System is substantially equivalent to the Smith and Nephew Hysteroscopic Morcellation System K041774.
-
- Device Description The system consists of the following components:
- Control Unit o
- Morcellator Handpiece o
- Single Use Morcellator ಂ
- Footswitch O
The Interlace Medical Hysteroscopic Morcellation System will be used with standard hysteroscopes and fluid management systems.
-
- Intended Use
The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
- Intended Use
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Interlace Medical Inc.
Premarket Notification
Hysteroscopic Morcellation System
- Comparison of Technological Characteristics The principles of operation of the Interlace Medical Hysteroscopic Morcellation System are identical to those of the predicate device, the Smith and Nephew Hysteroscopic Morcellation System K041774. A disposable straight surgical morcellator is inserted into a morcellator handpiece for tissue removal. A footswitch is used to turn the morcellator on and off. The morcellator consists of a rotating and reciprocating inner tube or cutter that is totally contained within an outer tube and has a fitting at its proximal end to which vacuum tubing is attached. The outer tube incorporates a "cutting window" through which targeted tissue is pulled, cut, and moved back through the inner tube to a collection canister.
7 Performance Testing The Interlace Medical Hysteroscopic Morcellation System meets electrical safety and EMC standards. In addition, an in-vitro test was conducted which demonstrated that the device performs equivalent to or better than the predicate device.
8. Statement of Equivalency
The Interlace 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 Morcellator has the same in intended use and technological characteristics as the predicate device, the Interlace Morcellator does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.
The descriptive characteristics demonstrate that the Interlace Morcellator is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 7 2008
Mr. Ron Adams Chief Technical Officer Interlace™ Medical 139 Newbury Street FRAMINGHAM MA 01701
Re: K073690
,
Trade/Device Name: Interlace Medical Hysteroscopic Morcellation System Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: March 27, 2008 Received: March 28, 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 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.
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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 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 C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K073690
Device Name: Interlace Medical Hysteroscopic Morcellation System
Indications For Use:
The Interlace Medical Hysteroscopic Morcellation 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)
Judd Lewin
Page 1 of |
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
§ 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.